DEVELOPMENT REPORT - New Treatment for Sleeping Sickness
欧盟GMP指南中文版
QbR Frequently Asked QuestionsDisclaimer: These are general answers and may not be applicable to every product. Each ANDA is reviewed individually. This document represents the Office of Generic Drugs’s (OGD’s) current thinking on these topics.Format and SubmissionHow should QbR ANDAs be submitted?OGD’s QbR was designed with the expectation that ANDA applications would beorganized according to the Common Technical Document (CTD) format, a submissionformat adopted by multiple regulatory bodies including FDA. Generic firms are strongly recommended to submit their ANDAs in the CTD format (either eCTD or paper) tofacilitate implementation of the QbR. The ANDA Checklist for completeness andacceptability of an application for filing can be found on the OGD web page:/cder/ogd/anda_checklist.pdf .What is a QOS?The Quality Overall Summary (QOS) is the part of the CTD format that provides asummary of the CMC aspects of the application. It is an important tool to make the QbR review process more efficient.How long should a QOS be?OGD believes the CTD guidance1 recommendation of 40 pages to be an appropriatecompromise between level of detail and concision. The CTD guidance recommendation does not include tables and figures.The same information should not be included in multiple locations in the QOS. Instead of repeating information, refer to the first location of the original information in the QOS by CTD section number.Should the QOS be submitted electronically?All applications should include an electronic QOS. For paper submissions, it isrecommended that both an electronic QOS and a paper QOS be included.What file format should be used for the QOS?All applications, both eCTD and paper submissions, should have an electronic QOS. The electronic QOS should be contained in one document. Do not provide separate files foreach section or question.The electronic QOS should be provided as both a pdf and a Microsoft Word file. Microsoft Word files should be readable by Word 2003.1 Guidance for Industry M4Q: The CTD – Quality (August 2001) /cder/guidance/4539Q.htmWhat fonts should be used in the QOS?Because of FDA’s internal data management systems, please use only use these TrueType fonts: Times New Roman, Arial, Courier New. Times New Roman is recommended as the main text font.Should the applicable QbR question be presented within the body of Module 2 of the relevant section, followed by sponsor's answer?Yes, include all the QbR questions without deletion in the QOS.Can the granularity of module 3 be used in module 2?Yes, the granularity can be used for section and subsection headings. However, the QOS should always be submitted as a single file.Can color be used in the QOS?Yes, but sponsors should ensure that the QOS is legible when printed in black and white.Colored text should not be used.Is the QOS format available on OGD webpage and questions therein mandatory to be followed?For an efficient review process, OGD desires all applications to be in a consistent format.See the OGD QbR questions and example QOS:/cder/ogd/QbR-Quality_Overall_Summary_Outline.doc/cder/ogd/OGD_Model_Quality_Overall_ Summary.pdf/cder/ogd/OGD_Model_QOS_IR_Product.pdfFor amendments to applications, should the documentation consist of a revision of the QOS? Would new PD reports be required?The QOS should not be updated after submission of the original ANDA. Any additional data (including any new PD reports) should be provided as a stand alone amendment.Responses to deficiencies should be provided in electronic format as both a pdf andMicrosoft Word file.After January 2007, what will happen to an application that does not have a QOS or contains an incomplete QOS?OGD will contact the sponsor and ask them to provide a QOS. If the sponsor provides the QOS before the application comes up for review, OGD will use the sponsor’s QOS.OGD’s QbR questions represent the current thinking about what information is essential to evaluate an ANDA. Reviewers will use deficiency letters to ask ANDA sponsors thequestions that are not answered in the sponsor’s QOS.In February 2007, 75% of ANDAs submitted contained a QOS.If a question is not applicable to a specific formulation or dosage form, should the question be deleted or unanswered?Sponsors should never delete a QbR question, but instead answer as not applicable, with a brief justification. Please answer all parts of multi-part questions.For sterile injectables, to what extent should sterility assurance be covered in QOS?The current QbR was not intended to cover data recommendations for Sterility Assurance information. In the future, other summaries will cover other disciplines.MAPP 5040.1, effective date 5/24/04, specifies location of the microbiology information in the CTD format.Where in the CTD should an applicant provide comparative dissolution data between the generic and RLD?The comparison between the final ANDA formulation and the RLD should be provided in5.3.1, this comparison should be summarized in the QOS. Comparisons with otherformulations conducted during development should be included in 3.P.2.Is it possible to submit an amendment in CTD format for a product that was already submitted in the old ANDA format?No, all amendments to an application under review should use the same format as theoriginal submission.How is a paper CTD to be paginated?“Page numbering in the CTD format should be at the document level and not at the volume or module level. (The entire submission should never be numbered consecutively by page.) In general, all documents should have page numbers. Since the page numbering is at the document level, there should only be one set of page numbers for each document.”2. For paper submission, tabs locating sections and subsections are useful.For the ANDA submitted as in paper CTD format, can we submit the bioequivalence study report electronically? Or does the Agency require paper copy only?The bioequivalence summary tables should always be provided in electronic format.Will QbR lead to longer review times?Many of the current long review times result from applications that do not completelyaddress all of the review issues and OGD must request additional information through the deficiency process. This iterative process will be reduced with the use of the QbR template.Sponsors that provide a QOS that clearly and completely addresses all the questions in the QbR should find a reduction in the overall review time.Will DMFs for the drug substance be required to be in CTD if the ANDA is in CTD format?No. CTD format DMFs are recommended.What should be included in 3.2.R.1.P.2, Information on Components?COA’s for drug substance, excipients and packaging components used to produce theexhibit batch.2 Submitting Marketing Applications According to the ICH/CTD Format: General Considerations/cder/guidance/4707dft.pdfHow should an ANDA sponsor respond to deficiencies?OGD requests that sponsors provide a copy of the response to deficiencies in electronic format as both a pdf file and a Microsoft Word file.QUALITY OVERALL SUMMARY CONTENT QUESTIONS2.3 Introduction to the Quality Overall SummaryWhat information should be provided in the introduction?Proprietary Name of Drug Product:Non-Proprietary Name of Drug Product:Non-Proprietary Name of Drug Substance:Company Name:Dosage Form:Strength(s):Route of Administration:Proposed Indication(s):Maximum Daily Dose:2.3.S DRUG SUBSTANCEWhat if an ANDA contains two or more active ingredients?Prepare separate 2.3.S sections of the QOS for each API. Label them 2.3.S [API 1] and2.3.S [API 2].What if an ANDA contains two or more suppliers of the same active ingredient?Provide one 2.3.S section. Information that is common between suppliers should not be repeated. Information that is not common between suppliers (e.g. different manufacturing processes) should have separate sections and be labeled accordingly (drug substance,manufacturer 1) and (drug substance, manufacturer 2).Can information in this section be provided by reference to a DMF?See individual questions for details. As a general overview:•Information to be referenced to the DMFo Drug substance structure elucidation;o Drug substance manufacturing process and controls;o Container/closure system used for packaging and storage of the drugsubstance;o Drug substance stability.•Information requested from ANDA Sponsoro Physicochemical properties;o Adequate drug substance specification and test methods including structure confirmation;o Impurity profile in drug substance (process impurity or degradant);o Limits for impurity/residual solvent limits;o Method validation/verification;o Reference standard.2.3.S.1 General InformationWhat are the nomenclature, molecular structure, molecular formula, and molecular weight?What format should be used for this information?Chemical Name:CAS #:USAN:Molecular Structure:Molecular Formula:Molecular Weight:What are the physicochemical properties including physical description, pKa, polymorphism, aqueous solubility (as function of pH), hygroscopicity, melting point, and partition coefficient?What format should be used for this information?Physical Description:pKa:Polymorphism:Solubility Characteristics:Hygroscopicity:Melting Point:Partition Coefficient:Should all of these properties be reported? Even if they are not critical?Report ALL physicochemical properties listed in the question even if they are not critical.If a property is not quantified, explain why, for example: “No pKa because there are no ionizable groups in the chemical structure” or “No melting point because compounddegrades on heating”.What solubility data should be provided?The BCS solubility classification3 of the drug substance should be determined for oral dosage forms.Report aqueous solubility as a function of pH at 37º C in tabular form. Provide actualvalues for the solubility and not descriptive phrases such as “slightly soluble”.3 See BCS guidance /cder/guidance/3618fnl.pdf for definitionSolvent Media and pH Solubility Form I(mg/ml) Solubility Form II(mg/ml)Should pH-solubility profiles be provided for all known polymorphic forms?No, it is essential that the pH-solubility profile be provided for the form present in the drug product. The relative solubility (at one pH) should be provided for any other more stable forms.Physicochemical information such as polymorphic form, pKa, solubility, is usually in the confidential section of DMF. Is reference to a DMF acceptable for this type of information?No, knowledge of API physicochemical properties is crucial to the successful development of a robust formulation and manufacturing process. In view of the critical nature of thisinformation, OGD does not consider simple reference to the DMF to be acceptable.The Guidance for Industry: M4Q: The CTD-Quality Questions and Answers/ Location Issues says only the polymorphic form used in the drug product should be described in S.1 and other known polymorphic forms should be described in S.3. OGD’s examples placed information about all known polymorphic forms in S.1. Where does OGD want this information?This information may be included in either S.1 or in S.3. Wherever presented, list allpolymorphic forms reported in literature and provide brief discussion (i.e., which one is the most stable form) and indicate which form is used for this product.Other polymorph information should be presented by the ANDA applicant as follows: • 2.3.S.3 Characterization: Studies performed (if any) and methods used to identify the potential polymorphic forms of the drug substance. (x-ray, DSC, and literature) • 2.3.S.4 Specification: Justification of whether a polymorph specification is needed and the proposed analytical method• 2.3.P.2.1.1 Pharmaceutical Development –Drug Substance: Studies conducted to evaluate if polymorphic form affects drug product propertiesWhy does OGD need to know the partition coefficient and other physicochemical properties?Physical and chemical properties may affect drug product development, manufacture, or performance.2.3.S.2 ManufactureWho manufactures the drug substance?How should this be answered?Provide the name, address, and responsibility of each manufacturer, including contractor, and each proposed production site or facility involved in manufacturing and testing.Include the DMF number, refer to the Letter of Authorization in the body of data, andidentify the US Agent (if applicable)How do the manufacturing processes and controls ensure consistent production of the drug substance?Can this question be answered by reference to a DMF?Yes. It is preferable to mention the source of the material (synthetic or natural) when both sources are available.The DMF holder’s COA for the batch used to manufacture the exhibit batches should be provided in the body of data at 3.2.S.4.4.If there is no DMF, what information should be provided?A complete description of the manufacturing process and controls used to produce the drugsubstance.2.3.S.3 CharacterizationHow was the drug substance structure elucidated and characterized?Can structure elucidation be answered by reference to a DMF?Yes.What information should be provided for chiral drug substances?When the drug substance contains one or more chiral centers, the applicant should indicate whether it is a racemate or a specific enantiomer.When the drug substance is a specific enantiomer, then tests to identify and/or quantify that enantiomer should be included. Discussion of chirality should include the potential forinterconversion between enantiomers (e.g. racemization/epimerization).How were potential impurities identified and characterized?List related compounds potentially present in the drug substance. Identify impurities bynames, structures, or RRT/HPLC. Under origin, classify impurities as process impurities and/or degradants.Structure Origin ID ChemicalName[SpecifiedImpurity]Is identification of potential impurities needed if there is a USP related substances method?Yes.Can this question be answered by reference to a DMF?The ANDA should include a list of potential impurities and their origins. The methodsused to identify and characterize these impurities can be incorporated by reference to the DMF.According to the CTD guidance, section S.3 should contain a list of potential impurities and the basis for the acceptance criteria for impurities, however in the OGD examples this information was in section S.4. Where should it go?This information may be included in either S.3 or in S.4.2.3.S.4 Control of Drug SubstanceWhat is the drug substance specification? Does it include all the critical drug substance attributes that affect the manufacturing and quality of the drug product?What format should be used for presenting the specification?Include a table of specifications. Include the results for the batch(es) of drug substance used to produce the exhibit batch(es). Identify impurities in a footnote. Test results and acceptance criteria should be provided as numerical values with proper units whenapplicable.Tests Acceptancecriteria AnalyticalprocedureTest results for Lot#AppearanceIdentificationA:B:AssayResidualSolventsSpecified ImpuritiesRC1RC2RC3Any UnspecifiedImpurityTotal Impurities[AdditionalSpecification]*RC 1: [impurity identity]RC 2: [impurity identity]RC 3: [impurity identity]What tests should be included in the drug substance specification?USP drugs must meet the USP monograph requirements, but other tests should be included when appropriate. For USP and non USP drugs, other references (EP, BP, JP, the DMF holder’s specifications, and ICH guidances) can be used to help identify appropriate tests.Only relevant tests should be included in the specification. Justify whether specific tests such as optical rotation, water content, impurities, residual solvents; solid state properties(e.g. polymorphic form, particle size distribution, etc) should be included in thespecification of drug substance or not.Does OGD accept foreign pharmacopeia tests and criteria for drug substances?There are several examples where a drug substance is covered by a monograph in EP or JP, but not in the USP. ANDA and DMF holders can obtain information regardingphysicochemical properties, structure of related impurities, storage conditions, analytical test methods, and reference standards from EP or JP to support their submission to OGD.Although the USP remains our official compendium, we usually accept EP when the drug substance is not in USP (However, a complete validation report for EP methods should be provided in the ANDA).For each test in the specification, is the analytical method(s) suitable for its intended use and, if necessary, validated? What is the justification for the acceptance criterion?What level of detail does OGD expect for the analytical method justifications and validations?Provide a summary of each non-USP method. This can be in a tabular or descriptive form.It should include the critical parameters for the method and system suitability criteria ifapplicable. See an example in section 2.3.P.5 of this document.For each analytical procedure, provide a page number/link to the location of validationinformation in Module 3. For quantitative non-compendial analytical methods, provide a summary table for the method validation. See an example in section 2.3.P.5 of thisdocument.Is validation needed for a USP method?No, but USP methods should be verified and an ANDA sponsor should ensure that theUSP assay method is specific (e.g. main peak can be separated from all process impurities arising from their manufacturing process and from degradation products) and the USPrelated substance method is specific (e.g. all the process impurities and degradants can be separated from each other and also separated from main peak).Is validation needed if the USP method is modified or replaced by an in-house method?Yes. Data supporting the equivalence or superiority of the in-house method should beprovided. In case of a dispute, the USP method will be considered the official method.Is reference to the DMF for drug substance analytical method validations acceptable?No. ANDA sponsors need to either provide full validation reports from the ANDA holder or reference full validation reports from the DMF holder (provided there is a copy of the method validation report in the ANDA and method verification from the ANDA holder). AppearanceIdentityAssayImpurities (Organic impurities)What format should be used for related substances?List related compounds potentially present in the drug substance. (Either here or S.3)Name Structure Origin[SpecifiedImpurity]Provide batch results and justifications for the proposed acceptance criteria. See guidance on ANDA DS impurities4 for acceptable justifications. If the DS is compendial, include the USP limits in the table. If the RLD product is used for justification/qualification, then its results should also be included. If an ICH justification is used, then the calculation of the ICH limits should be explained.To use the ICH limits, determine the Maximum Daily Dose (MDD) indicated in the label and use it to calculate the ICH Thresholds: Reporting Threshold (RT), Identification1. The amount of drug substance administered per day2. Higher reporting thresholds should be scientifically justified3. Lower thresholds can be appropriate if the impurity is unusually toxicSponsors can use the ICH limits to ensure the LOQ for the analytical method is equal or below the RT, establish the limit for “Any Unspecified Impurity” to equal or below the IT, and establish limits for each “Specified Identified Impurity” and each “SpecifiedUnidentified Impurity”5 to equal or below the QT.An impurity must be qualified if a limit is established above the QT. Options forqualification include reference to the specific impurity listed in a USP monograph,comparison to the RLD product, identifying the impurity as a significant metabolite of the drug substance, literature references including other compendial monographs (EP, BP, JP), or conducting a toxicity study.4/cder/guidance/6422dft.pdf5 The ANDA DS guidance states “For unidentified impurities to be listed in the drug substance specification, we recommend that you clearly state the procedure used and assumptions made in establishing the level of the impurity. It is important that unidentified specified impurities be referred to by an appropriate qualitative analytical descriptive label (e.g., unidentified A, unidentified with relative retention of 0.9)”. Q3A(R) states “When identification of an impurity is not feasible, a summary of the laboratory studies demonstrating the unsuccessful effort should be included in the application.”Name DrugSubstance(Lot #)USPLimit forDrugSubstanceRLDDrugProduct(Lot #)ProposedAcceptancecriteriaJustification[Specified Impurity,Identified][BatchResults][BatchResults][SpecifiedImpurity,Unidentified]Any UnspecifiedImpurityTotalImpuritiesInclude the column for RLD drug product only if that data is used to justify the drugsubstance limit (example a process impurity that is also found in the RLD).What is OGD’s policy on genotoxic impurities?FDA is developing a guidance for genotoxic impurities. According to the ICH Q3A lower thresholds are appropriate for impurities that are unusally toxic.If impurities levels for an approved generic drug are higher than the RLD, can the approved generic drug data be used as justification for a higher impurity specification?According to ANDA DP and DS Impurity guidances, any approved drug product can be used to qualify an impurity level. However, the guidances qualify this by later stating “This approved human drug product is generally the reference listed drug (RLD). However, you may also compare the profile to a different drug product with the same route ofadministration and similar characteristics (e.g. tablet versus capsule) if samples of thereference listed drug are unavailable or in the case of an ANDA submitted pursuant to a suitability petition.”What if there are no impurities’ tests found in the USP monograph for a USP drug substance? What should the ANDA sponsor do?Please work with your supplier (DMF Holder) to ensure that potential synthetic process impurities (e.g. isomers (if any), side reaction products), degradation impurities, metalcatalysts, and residual solvents are adequately captured by your impurities test method.There may be information available in published literature as well, regarding potentialimpurities.Can levels of an impurity found in the RLD and identified by RRT be used for qualification?Qualification of a specified unidentified impurity by means of comparative RRT, UVspectra, and mass spectrometry with the RLD may be acceptable. However, the ANDAsponsor should make every attempt to identify the impurity.If levels are higher than in an approved drug product then the sponsor should provide data for qualification of the safety of this impurity at this level.Can a limit from a USP monograph for “any unspecified impurity” be used to justify a limit for “any unspecified impurity” greater than the ICH Q3 identification threshold?No. Any unspecified impurity (any unknown) limit should not exceed ICH Q3A “IT”based on MDD. Non-specific compendial acceptance criteria (e.g. Any Individual Impurity is NMT 0.5%) should not be used for justification of proposed impurity acceptance criteria.However, if the USP limit is less than the ICH threshold, then the USP limit should be used. Can a limit for an identified impurity in the drug substance be qualified with data obtained from RLD drug product samples treated under the stressed conditions?No. Test various samples of marketed drug product over the span of its shelf life (ideally, near the end of shelf-life). Data generated from accelerated or stressed studies of the RLD is considered inappropriate.Impurities (Residual Solvents)Will OGD base residual solvent acceptance limits on ICH limits or process capability?The ICH guidance on residual solvents6 provides safety limits for residual solvents but also indicates that “residual solvents should be removed to the extent possible”. ANDA residual solvent limits should be within the ICH safety limits, but the review of the ANDA includes both of these considerations.OGD generally accepts the ICH limits when they are applied to the drug product.What about solvents that are not listed in Q3C?Levels should be qualified for safety.Impurities (Inorganic impurities)Polymorphic FormWhen is a specification on polymorphic form necessary?See ANDA polymorphism guidance7 for a detailed discussion.Particle SizeWhen is a drug substance particle size specification necessary?A specification should be included when the particle size is critical to either drug productperformance or manufacturing.For example, in a dry blending process, the particle size distribution of the drug substance and excipients may affect the mixing process. For a low solubility drug, the drug substance particle size may have a critical impact on the dissolution of the drug product. For a high solubility drug, particle size is often not critical to product performance.6 /cder/guidance/Q3Cfnl.pdf7/cder/guidance/6154dft.pdfWhat justification is necessary for drug substance particle size specifications?As for other API properties, the specificity and range of acceptance criteria for particle size, and the justification thereof, could vary from none to very tight limits, depending upon the criticality of this property for that drug product.Particle size specifications should be justified based on whether a change in particle sizewill affect the ability to manufacture the product or the final product performance.In general, a sponsor either should demonstrate through mechanistic understanding orempirical experiments how changes in material characteristics such as particle size affecttheir product.In the absence of pharmaceutical development studies, the particle size specificationshould represent the material used to produce the exhibit batch.When should the particle size be specified as distribution [d90,d50,d10] and when is a single point limit appropriate?When critical, a particle size should be specified by the distribution. There may be othersituations when a single point limit can be justified by pharmaceutical development studies.2.3.S.5 Reference StandardsHow were the primary reference standards certified?For non-compendial, in-house reference standards, what type of qualification data is recommended? Will a COA be sufficient?COA should be included in Module 3, along with details of its preparation, qualification,and characterization. This should be summarized in the QOS.In terms of the qualification data that may be requested, it is expected that these reference standards be of the highest possible purity (e.g. may necessitate an additionalrecrystallization beyond those used in the normal manufacturing process of the activeingredient) and be fully characterized (e.g. may necessitate in the qualification reportadditional characterization information such as proof of structure via NMR) beyond theidentification tests that are typically reported in a drug substance COA. StandardLaboratory Practice for preparation of reference standards entails recrystallization toconstant physical measurements or to literature values for the pure material.2.3.S.6 Container Closure SystemWhat container closure is used for packaging and storage of the drug substance?Can this question be answered by reference to a DMF?Yes.。
人教版新高考英语一轮复习People of Achievement 卓有成就的人物
novel flow chart 名词(n.) politician
wormwood penicillin
disease disability territory cancer
theory genius patent relativity
assistance registration
institution institute formula passion confirmation military
词汇认知
词汇拓展
词汇应用
10.Did you come to any conclusions (结论)? 11.There is nothing we can do to help Linda. Her circumstances (状况) are beyond our control. 12.The gentle (温和的)genius was born in Germany on 14 March 1879. 13.While working there, out of a strong passion (酷爱)for knowledge, he continued to study, earning a doctorate in physics in 1905. 14.The same year, which was later recorded as a miracle year in science, he published four extraordinary (非凡的) physics papers.
词汇认知
词汇拓展
词汇应用
项目 副词(adv.)
短语(phr.)
课标词汇
非课标词汇
补充词汇
胰腺疾病(英文)课件
Monitoring changes
Regular follow-up exams can help monitor the progress of pancreatic diseases and adjust treatment plans accordingly.
acute pancreatitis
急性胰腺炎是一种突发的、严重 的胰腺炎症，通常由过量饮酒、 暴饮暴食、胆结石或其他因素引
起。
主要症状包括上腹部剧痛、恶心 、呕吐、发热和黄疸。
严重病例可能导致多器官功能衰 竭和死亡。
chronic pancreatitis
慢性胰腺炎是一种长期慢性的 胰腺炎症，通常由急性胰腺炎 反复发作或长期饮酒引起。
REPORT
CATALOG
DATE
ANALYSIS
SUMMAR Y
01
Байду номын сангаасThe anatomy and physiology of the pancreas
The anatomical structure of the pancreas
The pancreas is a long, narrow organ that lies across the back of the abdominal cavity, behind the
REPORT
CATALOG
DATE
ANALYSIS
SUMMAR Y
2021_2022学年新教材高中英语Unit1PeopleofAchievementReadinga
7. _b_o_i_l for 20 minutes 煮沸20分钟 8. traditional _b_o_ta_n_i_c_a_l treatments传统的植物疗法 9. _e_v_a_lu__a_te_ the result of the experiment评估实验结果 10. protect my _p_r_o_p_e_r_ty_保护我的财产 11. have some _d_i_st_i_n_c_t advantages 有一些明显的优势 12. take in plenty of _l_iq_u_i_d_摄入大量液体 13. _o_b_t_a_in_ approval 获得批准 14. acknowledge _d_e_f_ea_t_承认失败
(1)Why was Tu Youyou awarded the 2015 Nobel Prize for Physiology or Medicine?
A. Because she was a committed and patient scientist.
B. Because she saved 100, 000 lives in Africa.
Ningbo Graduated Worked
1971 2015
establish head
Physiology
3. Long sentence analysis. (1)This year’s Nobel Prize for Physiology or Medicine (主语) has been awarded to(谓语)Tu Youyou (co-winner)(宾语), whose research led to the discovery of artemisinin (定语从句), a crucial new treatment for malaria(同位语). 译文: 今年的诺贝尔生理学或医学奖授予了屠呦呦(共同获奖者), _她__的__研__究__引__ _起__了__青__蒿__素__的__发__现__, _这__是__一__种__至__关__重__要__的__治__疗__疟__疾__的__新__方__法__。
人教版高中英语选择性必修第三册精品课件 Unit 5 POEMS Unit 5单元提能强化练
Asked why she came up with the idea,Haley told Scary Mommy,“We don’t have art in our school,so I always try to do little creative projects when possible.” 【语篇导读】本文是一篇记叙文。文章讲述了一名叫Haley的老师为学生 提供一件白裙子,让他们在裙子上作画,以激发学生的创造力的故事。
ⅠⅡⅢ
B Paintings and sculptures can be a feast for the eyes of visitors to art museums,but today their viewing is also an unconventional treatment for people with mental illness. Last month,a group of Canadian doctors started to write a new kind of prescription(处方),which gives patients free access to the Montreal Museum of Fine Arts(MMFA).There,they will have a “relaxing,revitalizing experience” looking at the museum’s collections,according to MMFA.
Epigenetic Regulation of Development
Epigenetic Regulation of Development Epigenetic regulation of development is a complex process that involves the modification of gene expression without altering the DNA sequence. It plays a crucial role in various stages of development, including embryonic development, cell differentiation, and tissue-specific gene expression. Epigenetic modifications are heritable and reversible, making them an essential mechanism for regulating gene expression during development. In this essay, we will discuss the role of epigenetic regulation in development from different perspectives.From a biological perspective, epigenetic regulation is a fundamental mechanism that ensures the proper development of an organism. During embryonic development, cells undergo a series of epigenetic modifications that determine their fate and function. For example, DNA methylation, histone modification, and non-coding RNA regulation are essential epigenetic mechanisms that regulate gene expression during development. These modifications ensure that genes are expressed at the right time and in the right place, which is critical for proper development.From a medical perspective, epigenetic regulation plays a significant role in the development of various diseases. Epigenetic changes can alter gene expression and contribute to the development of cancer, neurological disorders, and other diseases. For example, aberrant DNA methylation patterns have been linked to the development of cancer. Understanding the epigenetic mechanisms that contribute to disease development can help in the development of new treatments and therapies.From an ethical perspective, epigenetic regulation raises ethical concerns about the manipulation of gene expression. Advances in epigenetic research have made it possible to manipulate gene expression and alter the development of an organism. This raises concerns about the potential misuse of this technology, such as the creation of designer babies. It is essential to consider the ethical implications of epigenetic research and ensure that it is used for the benefit of society.From a social perspective, epigenetic regulation has the potential to impact society in various ways. For example, epigenetic research can provide insights into the effects of environmental factors on gene expression and development. This can help in the development of public health policies and interventions that promote healthy development. Additionally, epigenetic research can help in the development of personalized medicine, which can lead to better health outcomes for individuals.From a personal perspective, epigenetic regulation is a fascinating area of research that has the potential to impact individuals' lives. Understanding the epigenetic mechanisms that regulate gene expression can provide insights into the development of diseases and potential treatments. Additionally, epigenetic research can help individuals make lifestyle choices that promote healthy development. For example, research has shown that environmental factors, such as diet and stress, can impact epigenetic modifications and alter gene expression. By understanding these mechanisms, individuals can make informed decisions about their health.In conclusion, epigenetic regulation plays a crucial role in development from various perspectives, including biological, medical, ethical, social, and personal. Understanding the epigenetic mechanisms that regulate gene expression can provide insights into the development of diseases and potential treatments. Additionally, epigenetic research can help in the development of public health policies and interventions that promote healthy development. However, it is essential to consider the ethical implications of epigenetic research and ensure that it is used for the benefit of society. Overall, epigenetic regulation is a fascinating area of research that has the potential to impact individuals' lives significantly.。
DEVELOPMENT REPORT - Tools for Development
DEVELOPMENT REPORT – July 29, 2002: Tools for DevelopmentBy Jill MossThis is the VOA Special English Development Report. Building things or making clothes can be difficult in developing countries, especially without the correct tools. However, an international humanitarian organization called CARE is trying to change this. CARE runs a special program called Tools for Development to help workers in developing countries.The Tools for Development program sells used tools and equipment at low cost to people who have small businesses. The tools are priced low enough so that poor people can buy them.Roy Megarry (Ma-GARY) started Tools for Development fifteen years ago. At thetime, he was the publisher of the Globe and Mail, a Canadian newspaper. MisterMegarry got the idea for the program while visiting a technical training school forboys in Lima, Peru.The Catholic priest who operated the school told Mister Megarry that the schoolneeded equipment for its training program. Mister Megarry sent a letter to thepresident of Sears Company in Canada requesting help. The company gaveequipment to the school in exchange for advertising in the newspaper. Today, Tools for Development receives free equipment and gifts from companies and organizations all over the world. Since the program began, more than two -thousand people have purchased more than six-thousand tools andequipment. They paid a total cost of one -million -two-hundred-thousand dollars. Mister Megarry says at least ten-thousand jobs have been saved or created because of the program. Money gained from the sale of the tools is used for loans, training and shipping costs.People can buy many kinds of equipment through Tools for Development. For example, there are tools for metal workers, shoemakers, pipe builders, clothing makers and people who fix vehicles. Some computers are also sold. Tools for Development is currently operating in Ecuador, Costa Rica and Jamaica. However, CARE is hoping to expand the program to other developing nations. You can learn more about Tools for Development. Write to CARE Canada, the Globe and Mail newspaper, four-four-four Front Street West, Toronto, Ontario, M-five -V, two-S-nine, Canada. Or you can visit the CARE Canada Internet Web site at w-w-w-dot-c-a-r-e-dot-c-a. This VOA Special English Development Report was written by Jill Moss.Email this article to a friendPrinter Friendly Version (Photo - CARE)。
oet练习题
OET练习题一、听力理解1. Listen to a conversation between a patient and a doctor. What is the patient's main concern?2. Listen to a short presentation about a new medical procedure. What are the potential risks mentioned?3. Listen to a doctor explaining a medical condition to a patient. What are the symptoms of the condition?4. Listen to a nurse describing the steps of a patient's treatment plan. What is the first step in the plan?5. Listen to a healthcare professional discussing the importance of hand hygiene. What are the key points made in the discussion?二、阅读理解1. Read an article about the impact of sleep on health. What are the main findings of the study?3. Read a report on the effectiveness of a new treatment for a chronic disease. What are the key results of the study?4. Read a case study about a patient who has been diagnosed with a rare condition. What are the challenges faced the patient and their family?5. Read an editorial about the importance of preventive healthcare. What are the main arguments presented in the editorial?三、写作1. Write a letter to a patient explaining the importance of following their medication regimen.2. Write a report on the findings of a medical study, including the methodology, results, and conclusions.3. Write a summary of a patient's medical history, highlighting the key symptoms and treatments.5. Write a reflective essay on the role of empathy in healthcare, providing personal examples to support your arguments.四、口语1. Discuss the importance of patient education in healthcare.2. Describe a challenging situation you have encountered in a healthcare setting and how you resolved it.4. Discuss the impact of technology on healthcare delivery.5. Describe a healthcare policy you believe should be implemented and why.OET练习题五、听力理解6. Listen to a healthcare professional discussing the importance of regular health checkups.7. Listen to a conversation between a nurse and a patient discussing postoperative care instructions.8. Listen to a doctor explaining the benefits of a new diagnostic test to a patient.9. Listen to a speech about the challenges of managing a chronic illness.10. Listen to a patient sharing their experience of dealing with a rare disease.六、阅读理解11. Read an article on the latest advancements in medical technology.13. Read a research paper on the effectiveness of alternative medicine in treating certain conditions.14. Read a policy document outlining the guidelines for managing patient confidentiality.15. Read a review of a new book on healthcare ethics.七、写作17. Write a memo to a healthcare team outlining the steps to be taken in the event of a medical emergency.18. Write a letter to a patient's family explaining the importance of home care following a hospital discharge.19. Write a press release announcing the opening of a new healthcare facility.20. Write a blog post discussing the role of nutrition in disease prevention.八、口语21. Discuss the role of interdisciplinary teams in healthcare.22. Describe a situation where you had to prioritize patient care and explain your decisionmaking process.24. Explain how healthcare professionals can support patients in managing stress.25. Discuss the challenges of maintaining worklife balance in the healthcare profession.九、听力理解26. Listen to a healthcare professional discussing the importance of mental health awareness.27. Listen to a conversation between a patient and a pharmacist discussing medication interactions.28. Listen to a talk about the impact of environmental factors on public health.29. Listen to a panel discussion on the future of telemedicine in healthcare.30. Listen to a patient sharing their experience of navigating the healthcare system.十、阅读理解31. Read an article on the global health crisis caused a pandemic.33. Read a review of a study on the effectiveness of a new vaccine.34. Read a policy brief on the challenges of healthcare accessibility in rural areas.OET练习题十一、听力理解36. Listen to a healthcare provider discussing the importance of patientcentered care.37. Listen to a patient describing their experience witha rehabilitation program.38. Listen to a doctor explaining the process of a medical procedure to a patient's family.39. Listen to a healthcare administrator discussing the challenges of managing a healthcare budget.40. Listen to a healthcare professional discussing the importance of infection control in healthcare settings.十二、阅读理解42. Read a patient education handout on managing diabetes through lifestyle changes.43. Read a research abstract on the effectiveness of a new treatment for a neurological disorder.45. Read a journal article on the psychological effects of longterm hospitalization.十三、写作46. Write a speech outline for a presentation on the importance of health literacy among patients.47. Write a brief report on the findings of a survey on patient satisfaction with healthcare services.48. Write a reflective essay on a personal experience that highlighted the importance of teamwork in healthcare.49. Write a press release announcing the launch of a new healthcare app.50. Write a letter to a healthcare provider expressing concerns about a patient's care and suggesting improvements.十四、口语51. Discuss the role of healthcare professionals in promoting health and wellness.53. Discuss the importance of patient confidentiality in the digital age.54. Explain how healthcare professionals can contribute to reducing healthcare disparities.55. Discuss the impact of burnout on healthcare professionals and strategies for prevention.十五、听力理解56. Listen to a healthcare professional discussing the use of telehealth in remote areas.57. Listen to a conversation between a nurse and a patient discussing the importance of followup appointments.58. Listen to a talk about the role of nutrition in the prevention of chronic diseases.59. Listen to a healthcare provider discussing the importance of patient advocacy.60. Listen to a patient sharing their experience with a support group for individuals with a similar condition.十六、阅读理解61. Read an editorial on the need for healthcare reform in the context of an aging population.63. Read a research paper on the effectiveness of mindfulness practices in healthcare settings.64. Read a policy analysis on the impact of healthcare policies on rural healthcare access.65. Read a book review on a healthcarerelated topic that has influenced your practice or understanding.OET练习题十七、听力理解66. Listen to a healthcare professional discussing the importance of health promotion in schools.67. Listen to a conversation between a doctor and a patient discussing the risks and benefits of a proposed surgery.68. Listen to a talk about the role of genetics in personalized medicine.69. Listen to a patient describing their experience witha rehabilitation program following an injury.70. Listen to a healthcare administrator discussing the challenges of implementing electronic health records (EHR) in a hospital.十八、阅读理解71. Read an article on the global burden of mental health issues and the need for increased resources.72. Read a patient information leaflet on the use of a new class of medications for managing chronic pain.73. Read a case study on the successful implementation ofa health information technology system in a healthcare organization.74. Read a report on the impact of climate change on public health and the need for adaptive strategies.75. Read a review of a study on the effectiveness of telemedicine in mental health care.十九、写作76. Write a letter to a healthcare professional requesting a referral to a specialist.79. Write a reflection on a recent healthcare training session and how it has improved your practice.80. Write a summary of a healthcare conference presentation, highlighting the key takeaways and implications for practice.二十、口语81. Discuss the importance of patient engagement in their own healthcare decisions.85. Discuss the challenges and benefits of working in a multicultural healthcare environment.二十一、听力理解. Listen to a healthcare provider discussing the importance of patient education in managing longterm conditions.87. Listen to a conversation between a nurse and apatient discussing the importance of medication adherence.88. Listen to a talk about the role of physical activity in preventing chronic diseases.89. Listen to a healthcare professional discussing the ethical considerations in endoflife care.90. Listen to a patient sharing their experience with a support group for individuals with a rare disease.二十二、阅读理解91. Read an article on the impact of sleep deprivation on healthcare professionals and patient care.92. Read a patient education guide on the signs and symptoms of a heart attack.93. Read a research paper on the effectiveness of mobile health applications in managing chronic diseases.94. Read a policy brief on the challenges of healthcare inequality and the need for equitable access.答案：一、听力理解1. What is the patient's main concern?2. What are the potential risks mentioned?3. What are the symptoms of the condition?4. What is the first step in the plan?5. What are the key points made in the discussion?二、阅读理解1. What are the main findings of the study?2. What are the possible side effects of the medication?3. What are the key results of the study?4. What are the challenges faced the patient and their family?5. What are the main arguments presented in the editorial?三、写作1. Write a letter to a patient explaining the importance of following their medication regimen.2. Write a report on the findings of a medical study, including the methodology, results, and conclusions.3. Write a summary of a patient's medical history, highlighting the key symptoms and treatments.5. Write a reflective essay on the role of empathy in healthcare, providing personal examples to support your arguments.四、口语1. Discuss the importance of patient education in healthcare.2. Describe a challenging situation you have encountered in a healthcare setting and how you resolved it.4. Discuss the impact of technology on healthcare delivery.5. Describe a healthcare policy you believe should be implemented and why.五、听力理解6. What is the importance of regular health checkups?7. What are the postoperative care instructions?8. What are the benefits of the new diagnostic test?9. What are the challenges of managing a chronic illness?10. What is the patient's experience with a rare disease?六、阅读理解11. What are the latest advancements in medical technology?13. What are the key findings of the study on alternative medicine?14. What are the guidelines for managing patient confidentiality?15. What are the main arguments presented in theeditorial on healthcare ethics?七、写作17. Write a memo to a healthcare team outlining the steps to be taken in the event of a medical emergency.18. Write a letter to a patient's family explaining the importance of home care following a hospital discharge.19. Write a press release announcing the opening of a new healthcare facility.20. Write a blog post discussing the role of nutrition in disease prevention.八、口语21. Discuss the role of interdisciplinary teams in healthcare.22. Describe a situation where you had to prioritize patient care and explain your decisionmaking process.24. Explain how healthcare professionals can support patients in managing stress.25. Discuss the challenges of maintaining worklife balance in the healthcare profession.九、听力理解26. What is the importance of patientcentered care?27. What are the medication interactions discussed?28. What are the environmental factors discussed?29. What is the impact of telemedicine in healthcare?30. What is the patient's experience with a rare disease?十、阅读理解31. What is the global health crisis caused a pandemic?33. What are the findings of the study on alternative medicine?34. What are the challenges of healthcare accessibility in rural areas?35. What are the ethical implications of genetic testing in medicine?。
ICH-指导原则文件目录
ICH 的论题主要分为四类，因此ICH 根据论题的类别不同而进行相应的编码分类：1.“Q”类论题：Q 代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。
Q1/Q2...Q10 都属于这种。
2.“S”类论题：S 代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。
3.“E”类论题：E 代表EFFICACY ，指那些与人类临床研究相关的课题。
4.“M”类论题：M 代表MULTIDISCIPLINARY，指那些不可单独划入以上三个分类的交叉涉及的论题。
1. Q1A(R2): Stability Testing of New Drug Substances and Products新原料药和制剂的稳定性试验2. Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验3. Q1C: Stability Testing for New Dosage Forms新剂型的稳定性试验4. Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and DrugProducts原料药和制剂稳定性试验的交叉和矩阵设计5. Q1E: Evaluation of Stability Data稳定性数据的评估6. Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III 和IV，药物注册申请所提供的稳定性数据7. Q2(R1): Validation of Analytical Procedures: Text and Methodology分析程序的验证：正文及方法论8. Q3A(R2): Impurities in New Drug Substances新原料药中的杂质9. Q3B(R2): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质10. Q3C(R5): Impurities: Guideline for Residual Solvents杂质：残留溶剂指南11. Q3C(R6): Impurities: Guideline for Residual SolventsPDE for Triethylamine and PDE for Methylisobutylketone杂质：残留溶剂指南三乙胺的日允许接触剂量及甲基异丁基酮的日允许接触剂量12. Q3D: Guideline for Elemental impurities主要杂质指南13. Q4A: Pharmacopoeial Harmonisation 药典的协调14. Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH RegionsICH 地区使用的药典正文评估和建议15. Q4B Annex1(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Residue on Ignition/Sulphated Ash General Chapter附录1 ICH 地区使用的药典正文评估和建议灼烧残渣/灰分通则16. Q4B Annex2(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter附录2 ICH 地区使用的药典正文评估和建议注射剂可提取体积测试通则17. Q4B Annex3(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter 附录3 地区使用的药典正文评估和建议颗粒污染物测试:不溶性微粒通则18. Q4B ANNEX 4A(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Microbial Enumerations Tests General Chapter附录4A(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:微生物计数法通则19. Q4B ANNEX 4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Test for Specified Micro-organisms General Chapter附录4B(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:控制菌检查法通则20. Q4B ANNEX 4C(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Microbiological Examination of Non-sterile Products ：Acceptance Criteria For Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter附录4C(R1) 地区使用的药典正文评估和建议非无菌产品微生物检验:药物制剂及原料药的认可标准通则21. Q4B ANNEX 5(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Disintegration Test General Chapter附录5(R1) ICH 地区使用的药典正文评估和建议崩解试验通则22. Q4B ANNEX 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Uniformity of dosage units General Chapter附录6 ICH 地区使用的药典正文评估和建议含量均匀度通则word 格式-可编辑-感谢下载支持23. Q4B ANNEX 7(R2) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Dissolution Test General Chapter附录7(R2) ICH 地区使用的药典正文评估和建议溶解度测试通则24. Q4B ANNEX 8(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Sterility Test General Chapter附录8(R1) ICH 地区使用的药典正文评估和建议无菌检查通则25. Q4B ANNEX 9(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Tablet Friability General Chapter附录9(R1) ICH 地区使用的药典正文评估和建议片剂脆碎度检查通则26. Q4B ANNEX 10(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use inthe ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter附录10(R1) ICH 地区使用的药典正文评估和建议聚丙烯酰胺凝胶电泳通则27. Q4B ANNEX 11 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Capillary Electrophoresis General Chapter附录11 ICH 地区使用的药典正文评估和建议毛细管电泳通则28. Q4B ANNEX 12 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Analytical Sieving General Chapter附录12 ICH 地区使用的药典正文评估和建议分析筛选通则29. Q4B ANNEX 13 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Bulk Density and Tapped Density of Powders General Chapter附录13 ICH 地区使用的药典正文评估和建议粉末的松密度与密切度30. Q4B ANNEX 14 Evaluation and Recommendation of Pharmacopoeial Texts for Use in theICH Regions on Bacterial Endotoxins Test General Chapter附录14 ICH 地区使用的药典正文评估和建议细菌内毒素检测通则31. Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines ofHuman or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估32. Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in CellsUsed for Production of r-DNA Derived Protein Products生物技术产品的质量：rDNA 衍生蛋白质产品生产细胞的表达构建体分析33. Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/BiologicalProducts生物技术产品的质量：生物技术产品/生物制品的稳定性试验34. Q5D: Derivation and Characterization of Cell Substrates Used for Production ofBiotechnological/Biological Products用于生产生物技术产品/生物制品的细胞基质的来源和鉴定35. Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in TheirManufacturing Process生产工艺变更后生物技术产品/生物制品的可比性质量标准36. Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances andNew Drug Products: Chemical Substances (including decision trees)规范：新原料药和新制剂的检测方法和可接收标准：化学物质(包括决定过程)37. Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/BiologicalProducts规范：生物技术产品/生物制品的检验方法和可接收标准38. Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients药物活性成份的GMP 指南39. Q8(R2): Pharmaceutical Development药物开辟40. Q9: Quality Risk Management质量风险管理41. Q10: Pharmaceutical Quality System药物质量体系42. Q11:Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities)原料药的开辟与创造(化学实体与生物技术/生物制品实体)1. S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌试验的必要性2. S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌试验3. S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌试验的剂量选择4. S2(R1) : Guidance on Genotoxicity Testing and Data Interpretation for PharmaceuticalsIntended for Human Use人用药物的遗传毒性试验和数据分析指导原则5. S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in ToxicityStudies毒物代谢动力学指南的注释：毒性研究中全身暴露的评价6. S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学：重复给药的组织分布研究指导原则7. S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent ToxicityTesting)动物体内慢性毒性持续时间的检验(啮齿类和非啮齿类毒性试验)8. S5(R2) : Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to MaleFertility药品的繁殖毒性检测及雄性生育力毒性9. S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术药品的临床前安全性试验10. S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药物的安全性药理研究11. S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QTInterval Prolongation) by Human Pharmaceuticals 人用药延迟心室复极化(QT 间期延长) 潜在作用的非临床评价指导原则12. S8: Immunotoxicity Studies for Human Pharmaceuticals人用药品的免疫毒理学研究13. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals抗癌药物的临床前评价14. S10: Photosafety Evaluation of Pharmaceuticals药物的光安全评价1. E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended forLong-Term Treatment of Non-Life-Threatening Conditions对非危及生命的疾病的长期治疗药物进行临床安全性评估的人群暴露程度2. E2A: Definitions and Standards for Expedited Reporting快速报告的定义和标准3. E2C(R2): Periodic Benefit-Risk Evaluation Report上市药品定期风险效益评估报告4. E2D: Post-Approval Safety Data Management: Definitions and Standards for ExpeditedReporting 批准后安全性数据管理：快速报告的定义和标准5. E2E: Pharmacovigilance Planning 药物警戒计划6. E2F: Development Safety Update Report 安全性更新报告7. E3: Structure and Content of Clinical Study Reports临床研究报告的结构与内容8. E4: Dose-Response Information to Support Drug Registration新药注册所需量-效关系的资料9. E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data对国外临床研究资料的种族因素的可接受性10. E6(R1): Good Clinical Practice: Consolidated Guideline药品临床研究规范(GCP)一致性指导原则11. E6(R2): Integrated Addendum to ich E6(R1): Guideline for Good Clinical Practice E6(R1)整合的附录：药品临床研究规范指南12. E7: Studies in Support of Special Populations: Geriatrics老年人群的临床研究13. E8: General Considerations for Clinical Trials临床研究总则14. E9: Statistical Principles for Clinical Trials临床研究统计原则15. E10: Choice of Control Group and Related Issues in Clinical Trials临床研究对照组的选择及相关问题16. E11: Clinical Investigation of Medicinal Products in the Pediatric Population儿童人群的临床研究17. E12: Principles for Clinical Evaluation of New Antihypertensive Drugs抗高血压新药的临床评价指导原则18. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and ProarrhythmicPotential for Non-Antiarrhythmic Drugs非抗心律失常药物致QT/QTc 间期延长及潜在心律失常作用的临床评价19. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, GenomicData and Sample Coding Categories基因组生物标记物、药物基因组学、遗传药理学、基因组数据和样本编码分类的定义20. E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structureand Format of Qualification Submissions与药物或者生物技术产品相关的生物标记物研发: 申请资料的内容、结构和格式21. E17: General principle on planning/designing Multi-Regional Clinical Trials规划多地区临床试验的普通原则22. E18: Guideline on Genomic Sampling and Management of Genomic Data基因组数据采集与管理的指导原则1. M3: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals药物进行人体临床试验和上市许可申请的临床前安全性研究指导原则2. M4(R3): Organisation of the Common Technical Document for the Registration ofPharmaceuticals for Human Use人用药物注册申请的通用技术文件组织结构3. M4E(R1): The Common Technical Document for Registration of Pharmaceuticals for HumanUse Clinical人用药物注册申请的通用技术文件：临床4. M4E(R2): Revision of M4E Guideline on Enhancing Format and Structure of Benefit-riskInformation in ICH EfficacyM4E 指南修订，优化临床研究风险评估的格式与结构5. M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Quality人用药物注册申请的通用技术文件：质量6. M4S(R2): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Safety人用药物注册申请的通用技术文件：安全性7. M4E(R1): The Common Technical Document for the Registration of Pharmaceuticals forHuman Use: Efficacy人用药物注册申请的通用技术文件：有效性8. M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals toLimit Potential Carcinogenic Risk为限制潜在致癌风险而对药物中DNA 活性(诱变性)杂质进行的评估和控制。
newsreport英语作文模板
newsreport英语作文模板English:In today's news report, it was announced that a major breakthrough has been made in the field of medical research. Scientists have discovered a new treatment for a rare disease that has affected thousands of people worldwide. The new treatment has shown promising results in clinical trials, with patients experiencing significant improvements in their condition. This groundbreaking discovery has the potential to not only save lives but also improve the quality of life for those suffering from this debilitating illness. Medical experts are hopeful that this new treatment will soon be available to all patients in need, marking a significant milestone in the fight against this disease.Chinese:在今天的新闻报道中，宣布在医学研究领域取得了重大突破。
科学家们发现了一种新的治疗方法，用于治疗一种罕见疾病，该疾病已经影响了全球数千人。
新的治疗方法在临床试验中显示出了令人振奋的结果，患者的病情明显改善。
VOA慢速英语011.Development Report
001.Increasing Food Security in Dry Areas of the Middle EastThis is the VOA Special English Development Report.Agricultural experts have launched a land and water management project in the Middle East. The project seeks to increase food security in dry areas. Researchers say the water availability in some of the areas has dropped well below the internationally recognized standard.Egypt, Iraq, Jordan, Lebanon, the West Bank, Syria and Yemen are all taking part in the project. It is part of a larger ten-year effort called the Water and Livelihoods Initiative. The project is also expected to increase household income for farmers in the areas.The United States Agency for International Development provided one million dollars for the Water and Livelihoods Initiative. Scott Christianson is an agricultural development advisor with U.S.A.I.D. He helped develop the project while working for the International Center for Agricultural Research in the Dry Areas. He says the countries taking part in the project were all carefully selected.SCOTT CHRISTIANSON: "They all share a socio-economic and cultural heritage that's fairly homogeneous. We feel that it's going to maximize our opportunity for trading of knowledge that we will generate in the project."Research by the International Center for Agricultural Research in the Dry Areas and its partners has already proven to be successful. New irrigation methods are expected to double wheat production while using one-third of the water required for full irrigation. Experts say the new methods also increase crop production up to five times more than crops that depend on rainfall only.The International Center for Agricultural Research in the Dry Areas will provide technical support for the project. Officials from the International Water Management Institute and the International Food Policy Research Institute are also taking part in the effort.Each team will be joined by experts from local research institutions, universities and government agencies.SCOTT CHRISTIANSON: "We have good partnerships among the countries within each agro-eco system so that through this twinning they can learn lessons from each other and work together effectively through time."Scott Christianson and other officials met in Amman, Jordan last week. They attended an international conference on food security and climate change in dry areas. Nearly one-fourth of the world's people live in these areas.Officials say more must be done to deal with water shortages in agriculture. If not, they say, the future of food security, economic development and social stability in dry areas will be put at risk.And that's the VOA Special English Development Report, written by June Simms. I'm Steve Ember.002.Breathing Easier: The Art of Stove Making27 January 2010More than three billion people are at risk from indoor air pollution because of the heating or cooking fuels they use. Most live in Africa, India and China. They use biomass fuels like wood, crop waste, animal waste or coal. These solid fuels may be the least costly fuels available. But they are also a major cause of health problems and death.For more than thirty years, the Aprovecho Research Center has been designing cleaner, low-cost cooking stoves for the developing world. Dean Still is the director of the group which is based in the United States. He notes a World Health Organization estimate that more than one and a half million people a year die from breathing smoke from solid fuels.DEAN STILL: "And half of the people on planet Earth every day use wood or biomass for cooking. These are the people on Earth who have less money, and the richer people use oil and gas. It's been estimated that wood is running out more quickly than oil and gas. And so it is very important for the poorer people to have very efficient stoves that protect their forests and that protect their health."Every year Aprovecho holds a "stove camp" at its testing station in Cottage Grove, Oregon. Engineers, inventors, students and others come together to design and test different methods and materials for improving stoves.Over the years, the group has made stoves using mud, bricks, sheet metal, clay, ceramics and old oil drums. Most of the stoves look like large, deep cooking pots. They have an opening at the bottom for the fire and a place on top to put a pot.In the late nineteen seventies, Aprovecho produced a popular stove called the Lorena. The Lorena was very good at reducing smoke and warming homes. But new tests years later found that it was not very efficient. The Lorena used twice as much wood as an open fire, and took much longer to heat food.Since then, Dean Still says they have experimented with countless other designs.DEAN STILL: "Our goal is to make a very inexpensive stove -- let's say five dollars -- that makes very, very little smoke, so it's safe for health, diminishes global warming and diminishes deforestation. And so it's an ongoing problem to work on."Aprovecho has now partnered with a stove manufacturer in China. The company is making Aprovecho's first mass produced stoves. They are said to use forty to fifty percent less wood than an open fire, and produce fifty to seventy-five percent less smoke. A company called StoveTec is selling them through its Web site for less than ten dollars. Dean Still says that more than one hundred thousand have been sold so far.003.Steps Urged to Prevent Snakebites, Improve TreatmentsThis is the VOA Special English Health Report.This is the VOA Special English Development Report.Snakes bite an estimated five and a half million people worldwide each year. Experts say tens of thousands of people die from venom poisoning.An untreated or incorrectly treated bite might require the removal of a bitten foot, for example, or an arm. Each year around four hundred thousand amputations are the result of snakebites.Last year, for the first time, the World Health Organization added snakebites to its list of "neglected tropical diseases." This recognition aims to bring greater attention to the problem.Scientists know of about three thousand kinds of snakes. About six hundred of them are venomous. These are most often found in rural areas in tropical climates.Asia and Africa have the highest number of snakebites -- together about four million a year. Latin America and islands in the South Pacific follow.The highest number of victims are agricultural workers. Snakebites are also common among fishermen, hunters and children. Many victims live in areas with poor or non-existent health care systems and where antivenom treatments are often not available.Antivenom is the only cure. But experts say antivenom technologies and their use need to be improved. Problems include a shortage of manufacturers and the high cost of treatment.Also, there is a widespread lack of knowledge among local health workers about how to use antivenoms. The treatments can cause dangerous and even deadly reactions if not used carefully.Antivenom contains proteins from animals such as horses or sheep. The animals are injected repeatedly with one or more different snake venoms to produce immunity.The Lancet medical journal recently published a series of reports on snakebite prevention and treatment. David Warrell at the University of Oxford in England co-wrote one of them. He praised efforts by the W.H.O. to establish common practices for the production, regulation and control of antivenom. But he says more must be done.The authors say community education programs could help prevent snakebites by teaching people how to avoid them. They also suggest actions like providing protective boots to wear while working in fields, and not sleeping on the ground.Also important is providing information about where dangerous snakes are most likely to live and when they are most active.004. New Vaccine Joins Campaign to End PolioTThis is the VOA Special English Development Report.The World Health Organization has begun to use a new vaccine against polio. Officials say it will become a major tool in the campaign to end a disease that mainly affects children under age five.The new formulation is known as B.O.P.V. , or bivalent oral polio vaccine. It was used for the first time in December in a polio immunization campaign in Afghanistan.Carol Pandak is with the PolioPlus program of the service organization Rotary International. She explains that health workers have been using what are called trivalent vaccines in some places. These are areas like Afghanistan where more than one kind of polio virus exists.There are three types of polio virus. The trivalent vaccine is least effective against type three, more effective against type one and highly effective against type two. As a result, few new casesof type two have been reported since nineteen ninety-nine.This has led to greater use of monovalent vaccines to protect against either type one or type three polio. But Carol Pandak says the monovalent vaccine is not enough in areas with both.CAROL PANDAK: "You address the type one, and the type three cases go up. You address the type three, and the type one cases go up."Rod Curtis at the World Health Organization in Geneva says the new bivalent vaccine solves this problem.ROD CURTIS: "The beauty of the bivalent vaccine is that it is able to attack both types of wild polio virus in one dose."Carol Pandak says tests found the new vaccine to be thirty percent more effective than the trivalent vaccine.More than thirty new cases of polio were reported in Afghanistan last year. About half were type one and the others type three. Rod Curtis says that shows the importance of the new vaccine targeting both viruses at once. Officials say similar vaccination campaigns are planned this year in India, Nigeria and Pakistan.Intensive vaccination campaigns have reduced the number of new polio cases reported worldwide to fewer than two thousand a year. The Global Polio Eradication Initiative says the number has fallen by ninety-nine percent since nineteen eighty eight.Polio is highly infectious. One victim in two hundred suffers permanent paralysis, usually in the legs. Five to ten percent of those victims die when their breathing muscles fail.005. Solar-Powered Pumps Aid African FarmersThis is the VOA Special English Development Report.A new study in West Africa shows how farm irrigation systems powered by the sun can produce more food and money for villagers. The study in Benin found that solar-powered pumps are effective in supplying water, especially during the long dry season.Sub-Saharan Africa is the part of the world with the least food security. The United Nations Food and Agriculture Organization estimates that more than one billion of the world's people faced hunger last year. Around two hundred sixty-five million of them live south of the Sahara Desert. Lack of rainfall is one of their main causes of food shortages.Jennifer Burney from Stanford University in California led the study. The research team helped build three solar-powered drip irrigation systems in northern Benin.Between thirty and thirty-five women used each system to pump water from the ground or a stream. Each woman was responsible for farming her own one hundred twenty square meters of land. They also farmed other land collectively.The solar-powered irrigation systems produced an average of nearly two metric tons of vegetables per month. During the first year, the women kept a monthly average of almost nine kilograms of vegetables for home use.They sold the surplus produce at local markets. The earnings greatly increased their ability to buy food during the dry season which can last six to nine months.People in the two villages with the systems were able to eat three to five more servings of vegetables per day. But making the surplus available at markets also had a wider effect.The study compared the villages with two others where women farmed with traditional methods like carrying water in buckets. The amount of vegetables eaten in those villages also increased, though not as much.The researchers note that only four percent of the cropland in sub-Saharan Africa is irrigated. Using solar power to pump water has higher costs at first. But the study says it can be more economical in the long term than using fuels like gasoline, diesel or kerosene. And solar power is environmentally friendly.The study appears this month in the Proceedings of the National Academy of Sciences.006. New Treatment for Sleeping SicknessThis is the VOA Special English Development Report.The World Health Organization is using a new combination of drugs to treat human African trypanosomiasis disease, also known as sleeping sickness. The drugs nifurtimox an eflornithine will be given out in Uganda and the Democratic Republic of Congo.Officials from the Drugs for Neglected Diseases Initiative say the new treatment has fewer side effects. It is also more effective and less costly than the drugs traditionally used. In addition, the new treatment reduces the number of injections needed. And it shortens the amount of time patients must spend in the hospital.Sleeping sickness threatens millions of people in thirty-six countries in Africa. Most live in poor rural areas. The disease is caused by the trypanosoma parasite. It is spread to humans through the bite of infected tsetse flies.Common signs of sleeping sickness include fever, headaches, extreme tiredness and pain in the muscles and joints. Early identification of the disease may be difficult because many infected people do not show any immediate symptoms.Over time, the parasites invade the central nervous system. The disease causes sleep disorders, mental confusion, personality changes, speech problems, seizures and coma. If left untreated, sleeping sickness kills.The World Health Organization estimates that about sixty thousand people are currently infected with the disease. It develops in two different forms. Trypanosoma gambiense is responsible for ninety percent of the reported cases of sleeping sickness. People infected with this form may develop the disease over many years without any major symptoms. The disease develops more quickly over a few weeks or months in people infected with trypanosoma rhodesiense.Until now the drug melarsoprol was used to treat patients in the advanced stage of sleeping sickness.But the drug requires many painful injections several times a day for several weeks. It also causes bad side effects, some of which can be deadly.In Uganda, a new study has confirmed earlier research linking the spread of sleeping sickness to infected farm animals. The writers of the study have called for stronger rules requiring cattle to be treated before being sold at market. The study was published in the Public Library of Science.007. Bringing Light to Homes in Poor CountriesThis is the VOA Special English Development Report.More than one and a half billion people around the world live without electricity. Finding better ways to bring light to the poor is the goal of researchers like David Irvine-Halliday.In the late nineteen nineties, the Canadian professor was working in Nepal when his return flight was canceled. A delay gave him time to take a fourteen-day hiking trip in the Himalayas.As he tells it, one day he looked in the window of a school and noticed how dark it was. This is a common problem for millions of children around the world -- and not just at school, but also at home.Many families use kerosene oil lamps. There are many problems with these lamps. They produce only a small amount of light. They are dangerous to breathe. And they are a big fire danger, causing many injuries and deaths each year.Kerosene costs less than other forms of lighting, but it is still costly in poor countries. Professor Irvine-Halliday says many people spend well over one hundred dollars a year on the fuel.When he returned to Canada, he began researching ways to provide safe, clean and affordable lighting. He began experimenting with light-emitting diodes, LEDs, at his laboratory at the University of Calgary in Alberta. As a professor of renewable energy, he already knew about the technology.Light-emitting diodes are small glass lamps that use much less electricity than traditional bulbs and last much longer.Professor Irvine-Halliday used a one-watt bright white L.E.D. made in Japan. He found it on the Internet and connected it to a bicycle-powered generator. He remembers thinking it was so bright, a child could read by the light of a single diode.In two thousand, after much research and many experiments, he returned to Nepal to put the systems into homes. His Light Up the World Foundation has now equipped the homes of twenty-five thousand people in fifty-one countries.DAVID IRVINE-HALLIDAY: "The one-time cost of our system -- which consists of a small solar panel, a little motorcycle-sized battery and a couple of LED lamps, which basically live forever, as well as the solar panel -- is less than one hundred dollars. So, one year of kerosene would pay for a solid-state lighting system."Now his aim is to develop a lower-cost lighting system. In January, David Irvine-Halliday is leaving the University of Calgary. He has also decided to give up leadership in the Light Up the World Foundation to start a company in India.And that's the VOA Special English Development Report, written by June Simms with Rosanne Skirble. I'm Christopher Cruise.008. Increase in Illegal Killing of Rhinos in Africa, AsiaThis is the VOA Special English Development Report.A new report says the illegal killing of rhinos for their horns is increasing in Africa and Asia.Rhinoceros poachers are killing an estimated two to three of the rare animals each week.Experts say demand in Asia -- especially Vietnam and China -- currently drives most trade in rhino horns from southern Africa. The horns are often used to make traditional medicines, or handles for dagger knives.The report is from the International Union for the Conservation of Nature and an organization known as Traffic.Most African rhino poaching is in Zimbabwe and South Africa. Experts found that two hundred ten rhinos were illegally killed in South Africa in the last three years.The estimate for Zimbabwe is two hundred thirty-five. The situation threatens gains made in its rhino populations in the nineteen nineties. In the last two years, only six people were found guilty of poaching charges out of forty-one arrested.In two thousand one, sixty-eight percent of African rhino horns entering illegal trade were recovered. By this year, nine out of ten were heading to Asian markets without interference.The report says poaching and illegal horn trade has increased in South Africa even with new measures against it.Adding to the problem, poachers today are more skilled at killing rhinos, and not only with guns. They also use quieter methods, like veterinary drugs, poison and crossbows.An international agreement on protecting endangered animals and plants provides for sport hunting of white rhinos in Africa. But the horns often enter illegal markets.Not all the news is bad, however. The report notes that rhino populations are increasing in some areas. These include both white rhinos and black rhinos in the wild in Africa.Africa had an estimated seventeen thousand white rhinos and four thousand black rhinos as of two years ago. Current estimates for Asia are around three thousand rhinos. But even with poaching, growth is reported in some areas of India and Nepal.Wildlife activists are urging governments to do more to fight rhino poaching.The report was presented to the organization known as CITES. CITES is the Convention on International Trade in Endangered Species of Wild Fauna and Flora. The next conference of countries that are parties to the agreement is in March in Doha, Qatar.009. Looking for New Ways to Fight MalariaThis is the VOA Special English Development Report.Scientists continue to seek better weapons against malaria. Each year the number of cases is in the hundreds of millions worldwide. Around a million people die, most of them in Africa. Economic losses from the disease amount to an estimated one percent of the African economy each year.George Dimopoulos is an associate professor at the Johns Hopkins Malaria Research Institute in Baltimore, Maryland.GEORGE DIMOPOULOS: "Forty-two percent of the earth's population live in areas where malaria transmitting mosquitoes exist. All of these people are in risk of being infected with malaria. The sad thing is that the majority of people that are killed by malaria are children because there immune system is not strong enough to ward off this infection."Malaria is caused by a parasite called Plasmodium. The organism is injected into peoplethrough the bite of infected mosquitoes. Malaria can be treated, but in many areas the parasites have become resistant to different drugs.George Dimopoulos and his team are studying ways to make mosquitoes resist infection by the parasite. There are hundreds of kinds of mosquitoes in the world. Most do not spread malaria. Some have immune systems that kill Plasmodium.GEORGE DIMOPOULOS: "We are particularly interested in these type of immune reactions that are responsible for killing the malaria parasite. Because we think once we understand how they work, we could be able to manipulate the mosquito genetically and convert mosquitoes that can transmit malaria into mosquitoes that cannot transmit malaria."The researchers have developed a way to make genetic changes in the three mosquito species known to spread malaria. The changes cause their systems to attack the parasite, blocking its development. Other researchers are working on ways to spread these genetically modified insects among mosquito populations.Professor Dimopoulos says there is still a long way to go, but current malaria research is highly promising.A new vaccine is in final testing. So far it has proven effective at preventing the disease in half of those vaccinated -- which is more than ever before.And at the Malaria Institute at Macha in Zambia, researchers are developing an easier way to identify malaria. The test uses saliva instead of blood to diagnose the infection.Current efforts in malaria control are mainly based on the use of insecticide sprays and treated bed nets. But George Dimopoulos says malaria needs to be attacked with drugs, with vaccines, with bed nets -- with whatever researchers can find.GEORGE DIMOPOULOS: "Malaria needs to be attacked with multiple weapons. There is not one magic bullet to control this disease."010. Some Tips for Cold Storage of FoodsThis is the VOA Special English Development Report.Before refrigerators were invented, the next best thing was an ice box. But another way to keep food fresh is to use an evaporative cooler. A common design is a tall box with several shelves inside to hold the food. The shelves are pieces of metal with many small holes through them. The sides of the box are covered with pieces of thick cloth.Containers of water are placed at the top and bottom of the cooler. The ends of each piece of cloth lie in the water so the cloth stays wet.The cooler is put outdoors, but not in the sun. Air will pass through the wet cloth. The inside of the box will stay several degrees cooler than the outside air temperature. And this may be cool enough to keep foods fresh, at least for a short time.Some foods can make you sick if they are stored in conditions that are not cold enough to prevent the growth of harmful organisms. Freezing can keep some foods in good condition for months after the growing season. Yet foods can be damaged if they are kept too cold.The British development group Practical Action says the best way to prepare foods for storage is at harvest time while still in the field.Use a sharp knife and place the harvested items on a clean surface or directly into storagecontainers. Do not put them on the ground.Use clean water to remove dirt, and keep the water clean. Usually it is better not to remove outer leaves from fruits and vegetables before storage. Without the leaves, food can become dry.Fruits and vegetables must be cool from field heat before they are put into storage. But cooling them in water can spread fungus throughout the food. A better idea is to harvest foods either early or late in the day, then leave them to cool naturally.Some fruits and vegetables must be stored at zero to four degrees Celsius. Any colder, and they might be damaged. Some foods need to be stored at four to eight degrees, and some need to be stored above eight degrees for best results.Wet the fruits and vegetables so they do not become too dry. The best time to do this is before storage. Cover the items in plastic once they reach the right "critical temperature" for storage. Most fruits and vegetables need the relative humidity in storage to be kept between eighty-five and ninety-five percent.Finally, leave space between the food containers and the walls of the cold storage area so air can flow. Keep the space clean. And try not to open the doors too often.011. Results of UN Food Summit Seen as DisappointingThis is the VOA Special English Development Report.Last week, the United Nations held a World Summit on Food Security. But the three-day meeting in Rome produced only limited measures to fight rising hunger. The U.N. World Food Program says more than a billion people -- one in six worldwide -- do not get enough food to be healthy.The troubled world economy is not the only cause of recent increases. The poorest countries continue to face high food prices, which have fallen elsewhere. The U.N. Food and Agriculture Organization says more than thirty nations continue to need emergency food assistance.Secretary General Ban Ki-moon said the food crisis has forced millions of families into poverty and hunger. He said six million children die of hunger every year. And he warned that food security is closely connected to the issue of climate change.BAN KI-MOON: "At a time when the global population is growing, our global climate is changing. By twenty fifty we will need to grow seventy percent more food. Yet weather is becoming more extreme and unpredictable."The delegates in Rome promised to continue efforts to reduce by half the number of hungry people by two thousand fifteen. But critics pointed out that world leaders made a similar promise more than ten years ago.Several countries promised to increase aid for agriculture, to help developing nations become more independent.Still, critics deplored a lack of greater action. Leaders from more than sixty countries were in Rome. But Italian Prime Minister Silvio Berlusconi was the only leader from a major industrial nation in the Group of Eight. An official from Kenya, Adam Barre Duale, said it showed a lack of unity in the fight against hunger.ADAM BARRE DUALE: "We need both the developed world and the developing countries to come together and to give and support a global initiative in the war against hunger."The Food and Agriculture Organization says more than forty billion dollars a year needs to be invested in agriculture to defeat world hunger. The growing problem has affected developing countries, but also industrialized nations.The government estimates that forty-nine million people in the United States were "food insecure" last year. That means their households, at some time during the year, had difficulty providing enough food for all members because of a lack of resources. Almost fifteen percent of all households were in that situation. And the Agriculture Department says the numbers may be even higher this year.012. Project Finds New Homes for Unwanted Bikes From USThis is the VOA Special English Development Report.Americans bought an estimated eighteen and a half million bicycles last year. Some bikes never get much riding. Mostly they gather dust. But a project based in Washington is putting unwanted bikes from the United States to good use in developing countries.Keith Oberg is the director of Bikes for the World.KEITH OBERG: "Everybody has an old bicycle, and it is usually not ridden. It sits there in the garage, or basement or shed, going to waste."Stephen Popick recently had two bikes to donate.STEPHEN POPICK: "I brought in two mountain bikes that my wife and I have ridden for the past ten years. My bikes wouldn't fetch a nice price and wouldn't be worth trying to sell, but they could be useful to somebody else."Bikes for the World collects bicycles and delivers them at low cost to community programs in developing countries. It shipped more than five thousand bikes during the first eight months of this year. Last year it shipped about ten thousand three hundred.The bicycle recycling program is one of the largest in the United States. It is a sponsored project of the Washington Area Bicyclist Association.Bikes for the World began in two thousand five. Since then it has shipped more than forty thousand bikes to communities in Africa, Latin America and the Caribbean, says director Keith Oberg.KEITH OBERG: "We work currently with partners in seven countries actively -- in Uganda, Ghana. We're talking to an organization that we would like to ship to in Liberia. We have shipped to Namibia and the Gambia in the past. And in Central America we ship to Panama, Costa Rica, Honduras, Guatemala, and we are talking to two organizations in El Salvador."Bikes for the World partners with nonprofit groups in the United States to collect unwanted bikes. Then it works with nonprofits in the other countries to get the bikes to organizations and individuals that need them the most.For example, the Bicycle Empowerment Network Namibia uses the bikes to provide transportation for health workers. That makes it possible for them to visit more patients each day. The organization also has bicycle ambulance services to transport the sick.The Bicycle Empowerment Network also provides training and support to help local。
医药行业专业英语词汇
医药行业专业英语词汇（非常有用）FDA和EDQM术语: CLINICAL?TRIAL：临床试验? ANIMAL?TRIAL：动物试验? ACCELERATED?APPROVAL：加速批准? STANDARD?DRUG：标准药物? INVESTIGATOR：研究人员；调研人员PREPARING?AND?SUBMITTING：起草和申报? SUBMISSION：申报；递交? BENIFIT （S）：受益? RISK（S）：受害? DRUG?PRODUCT：药物产品? DRUG?SUBSTANCE：原料药? ESTABLISHED?NAME：确定的名称? GENERIC?NAME：非专利名称? PROPRIETARY?NAME：专有名称；? INN（INTERNATIONAL?NONPROPRIETARY?NAME）：国际非专有名称? ADVERSE?EFFECT：副作用? ADVERSE?REACTION：不良反应? PROTOCOL：方案? ARCHIVAL?COPY：存档用副本? REVIEW?COPY：审查用副本? OFFICIAL?COMPENDIUM：法定药典（主要指USP、?NF）．? USP （THE?UNITED?STATES?PHARMACOPEIA）：美国药典NF（NATIONAL?FORMULARY）：（美国）国家处方集? OFFICIAL＝PHARMACOPEIAL=?COMPENDIAL：药典的；法定的；官方的? AGENCY：审理部门（指FDA）? IDENTITY：真伪；鉴别；特性? STRENGTH：规格；规格含量（每一剂量单位所含有效成分的量）? LABELED?AMOUNT：标示量? REGULATORY?SPECIFICATION：质量管理规格标准（NDA提供）? REGULATORY?METHODOLOGY：质量管理方法? REGULATORY?METHODS?VALIDATION：管理用分析方法的验证COS/CEP?欧洲药典符合性认证ICH（International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of PharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。
研究进展 英文
研究进展英文Research ProgressOver the years, significant advancements have been made in various fields of research. These breakthroughs have not only expanded our knowledge but also have the potential to transform our lives. In this article, we will discuss some of the recent research progress in different sectors.In the field of medicine, researchers have made significant strides in developing new treatments and improving existing ones. For instance, scientists have recently developed a groundbreaking gene-editing technology called CRISPR-Cas9, which allows for precise editing of genetic material. This technology has the potential to revolutionize the treatment of genetic diseases by correcting faulty genes. Furthermore, researchers have also made progress in cancer research, with the development of targeted therapies that are designed to specifically attack cancer cells while leaving healthy cells unharmed. These advancements offer hopefor improved treatment outcomes and better quality of life for patients.In the technology sector, researchers have been working on artificial intelligence (AI) and machine learning (ML) technologies. AI has the potential to transform various industries, from healthcare to transportation. For example, AI-powered algorithms can analyze vast amounts of medical data to identify patterns and make accurate diagnoses. In transportation, self-driving cars are being developed, which have the potential to reduce traffic accidents and increase transportation efficiency. Furthermore, theintegration of AI and ML in robotics has led to significant advancements in the field of automation and manufacturing.In the field of renewable energy, researchers have been working on improving the efficiency and affordability of solar and wind power. Solar panel technology has improved significantly, with the development of perovskite solar cells that are more efficient than traditional silicon-based cells. Meanwhile, advancements in wind turbine design have made wind power increasingly cost-effective and scalable. These developments are crucial in addressing the global challenge of climate change and transitioning to a more sustainable future.In the realm of space exploration, researchers have made significant progress in understanding the universe and expanding our knowledge of planets outside our solar system. The discovery of exoplanets – planets orbiting stars outside our solar system – has opened up new possibilities in the search for extraterrestrial life. Additionally, advancements in telescopes and space probes have allowed scientists to observe distant galaxies and study the evolution of the universe.It is evident that research progress across various fields is paving the way for a brighter and more innovative future. From breakthroughs in medicine and technology to advancements in renewable energy and space exploration, researchers continue to push the boundaries of what is possible. As we move forward, it is crucial to support and invest in research to foster further discoveries and advancements that have the potential to benefit humanity as a whole.。
38了不起的她——2022年高考英语最新热点时文阅读(含语法填空、七选五、阅读理解).docx
话题背景：历史的每一步前行、社会的每一点进步，都离不开女性的力量。
在新时代下，“妇女能顶半边天”这句话，说得不仅仅是女性地位的提升，它更多意味着，在各个领域，都有“巾帼英雄”，她们自强不息、开拓进取，为社会的发展，贡献着不可或缺的力量，展现着女性智慧和光芒。
今天是“三八”国际妇女节，我们一起感受不同时代女性不一样的力量与风采。
01（2022·陕西·西安中学二模）阅读下面短文，在空白处填入 1 个适当的单词或括号内单词的正确形式。
The home crowd erupted when China’s Eileen Gu won the Women’s Freeski Big Air gold in Beijing.Gu jumped into the top position with her third run, ____1____(score) 94.50. Her total score was 188.25 in the event’s debut at the Winter Olympics.The 18-year-old,who also ____2____(go) by her Chinese name, Gu Ailing, is a freestyle skier, model and grade-A student with ____3____ American father and a Chinese mother. She grew up in the United States. It was there ____4____ she grew to love skiing. By 2018, she was representing the US in the world cup for the sport.Then, she decided to switch from representing the US ____5____ representing China. The decision met with shock and ____6____(confuse) from her growing fan base but Gu was ____7____(determine), sharing her reasoning on Instagram at the time.“This was an ____8____(incredible) tough decision for me to make...Through skiing, I hope to unite people, promote common understanding, create communication and forge friendships between____9____(nation). If I can help to inspire one young girl ____10____(break) a boundary, my wishes will have come true.”02（2022·福建厦门·二模）阅读下面短文，在空白处填入1个适当的单词或括号内单词的正确形式。
发展预测研究报告英文
发展预测研究报告英文Development Forecast Research ReportAbstract:This research report aims to provide an analysis and forecast of the future development trends in various industries. It explores the potential growth opportunities and challenges that these industries may face. The report utilizes data from previous years, current market trends, and expert opinions to predict the future trajectory of these industries. The findings of this report can be used by businesses and policymakers to make informed decisions and develop strategies to ensure their continued success. Introduction:The purpose of this research report is to examine the future development prospects of various industries. By utilizing historical data and current market trends, this report aims to provide insights into the potential growth opportunities and challenges that these industries may face in the coming years.Methodology:To conduct this research, data was collected from various sources, including industry reports, market surveys, and expert opinions. The collected data was analyzed using statistical techniques to identify patterns and trends. These findings were then used to forecast the future development of the industries.Findings and Analysis:1. Information Technology: The IT industry is expected to continue its rapid growth in the next five years. Artificialintelligence, cloud computing, and blockchain technology are predicted to be key drivers of this growth. However, cybersecurity threats and privacy concerns may pose challenges in the future.2. Renewable Energy: The renewable energy sector is expected to experience significant growth in the coming years. Increasing environmental concerns and government initiatives to reduce carbon emissions are driving the demand for renewable energy sources such as solar and wind power.3. E-commerce: The e-commerce industry is projected to continue its upward trend. As more consumers embrace online shopping, retailers are focusing on enhancing their digital presence and improving customer experiences. The integration of augmented reality and virtual reality technologies is also anticipated to boost the growth of the e-commerce industry.4. Healthcare: With an aging population and advancements in medical technology, the healthcare industry is forecasted to expand. Telemedicine and digital health solutions are expected to play a crucial role in improving access to healthcare services and reducing healthcare costs.5. Artificial Intelligence: AI technologies such as machine learning and natural language processing are predicted to revolutionize various industries, including finance, logistics, and manufacturing. The development of autonomous vehicles and smart cities is projected to accelerate with the integration of AI.Conclusion:Based on the findings of this research report, it is evident that certain industries, such as information technology, renewable energy, e-commerce, healthcare, and artificial intelligence, are poised for significant growth in the future. However, challenges such as cybersecurity threats, environmental concerns, and privacy issues need to be addressed for sustained development. Businesses and policymakers can use these insights to make informed decisions and develop strategies to capitalize on the growth opportunities in these industries.。
动物医学实验报告英文
动物医学实验报告英文AbstractThe purpose of this experiment was to investigate the effectiveness of a new medication in treating a specific disease in animals. The experiment involved the use of a control group and a treatment group, with each group consisting of ten animals. The animals were closely monitored for a period of four weeks, and their health conditions were assessed regularly. It was found that the animals in the treatment group showed significant improvement in their symptoms compared to those in the control group. This suggests that the new medication may be an effective treatment option for the disease in animals.IntroductionAnimal veterinary medicine plays a crucial role in ensuring the health and well-being of animals. Experimental research in this field allows for the development of new treatments and therapies to combat various diseases that affect animals. Animal models are commonly used in such experiments as they mimic human physiology closely and provide valuable insights into the effectiveness and safety of new medications. This report presents the findings of an experiment conducted to evaluate the effectiveness of a new medication in treating a specific disease in animals.MethodsFor this experiment, twenty animals were divided into two groups: a control group and a treatment group. Each group consisted of ten animals. All animals were infected with the same disease and were chosen randomly to ensure a fair distribution. The control group received a placebo treatment, while the treatment group received the new medication.The animals' health conditions were assessed at the beginning of the experiment, and regular assessments were conducted every week for a period of four weeks. The assessments included measuring various health parameters like body temperature, heart rate, respiratory rate, and blood samples for laboratory analysis. The animals were also observed for any changes in behavior, appetite, and overall well-being. ResultsAnalysis of the data collected showed that the animals in the treatment group exhibited significant improvement in their symptoms compared to those in the control group. The animals in the treatment group had lower body temperatures, heart rates, and respiratory rates, indicating a reduction in discomfort and inflammation associated with the disease. The blood samples showed a decrease in infection markers and an increase in immune response indicators in the treatment group, suggesting that the new medication boosted the animals' immune systems. Additionally, the animals in the treatment group displayedincreased appetite and energy levels, indicating an overall improvement in their well-being.DiscussionThe results of this experiment suggest that the new medication is effective in treating the specific disease in animals. The lower body temperatures, heart rates, and respiratory rates observed in the treatment group indicate a reduction in inflammation, which is a common symptom of the disease. The decrease in infection markers and increase in immune response indicators suggest that the new medication improved the animals' immune systems, helping them fight off the disease. The increase in appetite and energy levels further support the positive outcomes of the treatment.However, further research is required to validate these findings and determine the long-term effects of the new medication. Additionally, it would be beneficial to conduct similar experiments on a larger number of animals to strengthen the conclusions and ensure the generalizability of the results.ConclusionIn conclusion, this experiment demonstrated the effectiveness of a new medication in treating a specific disease in animals. The animals in the treatment group exhibited significant improvement in their symptomscompared to those in the control group. These findings suggest that the new medication may serve as a valuable treatment option for the disease in animals. Further research and experiments are necessary to confirm these results and assess the long-term effects of the medication.。
心胸外科专题报告范文
心胸外科专题报告范文英文回答：Title: A Special Report on Cardiothoracic Surgery.Introduction:Cardiothoracic surgery is a specialized field of surgery that deals with diseases and conditions affecting the heart, lungs, and other organs in the chest. In this report, we will discuss the advancements, challenges, and future prospects in cardiothoracic surgery.Advancements in Cardiothoracic Surgery:Over the years, there have been significant advancements in cardiothoracic surgery techniques and technologies. Minimally invasive procedures, such as robotic-assisted surgery, have revolutionized the field by allowing surgeons to perform complex procedures withsmaller incisions, resulting in reduced pain, shorter hospital stays, and faster recovery times.中文回答：标题，心胸外科专题报告。
介绍：心胸外科是一门专门处理影响心脏、肺部和胸腔其他器官的疾病和病况的外科学科。
在本报告中，我们将讨论心胸外科手术的进展、挑战和未来前景。
2025年江苏省中考英语试卷及答案指导
2025年江苏省英语中考自测试卷及答案指导一、听力部分（本大题有20小题，每小题1分，共20分）1、听力原文：How are you doing today, Jane?I’m fine, thanks. And you?I’m also doing well. We’re planning to go hiking this weekend.Questions:1.What is Jane planning to do this weekend?A. Go swimmingB. Go hikingC. Go shoppingD. Go to a movieAnswer: BExplanation: Jane mentions that they are planning to go hiking this weekend, which is option B.2、听力原文：John: Hey, Sarah, have you heard about the new restaurant in town? Sarah: Yes, I have. It’s suppo sed to be amazing. They have this unique dish that everyone is talking about.Questions:2.What is Sarah’s opinion about the new restaurant?A. She thinks it’s terrible.B. She thinks it’s amazing.C. She thinks it’s average.D. She hasn’t heard about it.Answer: BExplanation: Sarah expresses her positive opinion about the new restaurant, saying that it’s supposed to be amazing, which corresponds to option B.3、You will hear a short conversation between two friends at a bookstore. Listen carefully and choose the best answer to the question that follows.Question: What is the main topic of the conversation?A) Finding a new jobB) Discussing a book they readC) Planning a vacationD) Deciding which book to buyAnswer: D) Deciding which book to buyExplanation: The conversation revolves around the friends discussing various books they are interested in purchasing, indicating that the main topic is about deciding which book to buy.4、You will hear a news report about a recent scientific discovery. Listen carefully and answer the question that follows.Question: According to the news report, what was the significance of thediscovery?A) It could lead to a new treatment for a common disease.B) It provides evidence of life on another planet.C) It solves the mystery of a long-lost historical event.D) It confirms the existence of a new element.Answer: A) It could lead to a new treatment for a common disease.Explanation: The news report highlights that the discovery could potentially have medical implications, suggesting a new treatment for a common disease, which makes it the most significant point mentioned in the report.5.You will hear a conversation between two friends, Tom and Lily. Listen carefully and choose the best answer to each question.Question 5: What is the main topic of the conversation?A. Their school lifeB. Their summer vacation planC. Their favorite foodD. Their new petAnswer: BExplanation: In the conversation, Tom and Lily are discussing their plans for the upcoming summer vacation, so the main topic is their summer vacation plan.6.You will hear a short talk about the importance of exercise. Listen carefully and answer the question.Question 6: According to the talk, what is one of the benefits of regularexercise?A. Improved memoryB. Better sleep qualityC. Increased stress levelsD. Reduced energy levelsAnswer: BExplanation: The speaker in the talk mentions that regular exercise can lead to better sleep quality, which is one of the benefits of staying physically active.7、Listen to the following conversation and answer the question.W: Hi, John. How was your trip to New York last week?M: It was amazing! I saw the Statue of Liberty, visited Central Park, and even went to a Broadway show.Q: What did John do during his trip to New York?A. He saw the Statue of Liberty and visited Central Park.B. He went to a concert in Central Park.C. He attended a sports game in New York.Answer: A. He saw the Statue of Liberty and visited Central Park. Explanation: The conversation indicates that John visited the Statue of Liberty and Central Park, which corresponds to option A.8、Listen to the following dialogue and answer the question.M: Have you finished your homework yet, Sarah?W: Not yet. I’m still working on the math problems. They’re really tricky.9.You will hear a conversation between two friends, discussing their weekend plans. Listen and choose the best answer to the question that follows.Question: What activity do both friends agree to do together on Saturday afternoon?A. Go to the movies.B. Visit the museum.C. Go for a hike.D. Have a picnic.Answer: C. Go for a hike.Explanation: The conversation mentions that they both enjoy nature and outdoor activities, and they decide to go for a hike together on Saturday afternoon.10.You will hear a news report about a recent scientific discovery. Listen and answer the question that follows.Question: What did the scientists discover about the new species they found in the Amazon rainforest?A. It is a new type of plant.B. It is a previously unknown species of bird.C. It is a tiny insect that helps with plant pollination.D. It is a rare species of tree that can survive in extreme conditions.Answer: B. It is a previously unknown species of bird.Explanation: The news report explicitly states that the scientists discovered a new species of bird during their expedition in the Amazon rainforest.11.Listen to the conversation between two friends at a bookstore and answer the question.What does the man suggest buying for the woman’s birthday?A. A novel by a popular author.B. A gift card for the bookstore.C. A book about cooking.D. A set of stationery.Answer: BExplanation: The man suggests giving the woman a gift card for the bookstore because he mentions, “How about a gift card? You can get whatever you want!”12.Listen to a short dialogue about a trip to the mountains and complete the sentence.The speaker plans to go hiking, but what does she say about the weather?A. It will be sunny and warm.B. It might rain, so they should take umbrellas.C. There could be snow, so they should wear warm clothes.D. The weather forecast is unclear.Answer: CExplanation: The speaker mentions, “The forecast says it might snow, so weshould take some warm clothes,” indicating that she anticipates cold weather and suggests dressing warmly for the hike.13.You will hear a conversation between two friends, Tom and Lucy, discussing their weekend plans. Listen carefully and answer the following question.Question: What activity do Tom and Lucy plan to do together on Saturday?A. Go to the beach.B. Visit a museum.C. Go hiking.Answer: B. Visit a museum.Explanation: In the conversation, Lucy suggests that they should visit the local museum since they both enjoy learning about history. Tom agrees and mentions that he heard there’s an interesting exhibit going on.14.Listen to a short interview with a travel blogger, Sarah, discussing her recent trip to Japan. Answer the following question based on the interview.Question: What is Sarah’s favorite part about traveling to Japan?A. The food.B. The culture.C. The scenery.Answer: B. The culture.Explanation: During the interview, Sarah talks about how much she loves the traditional Japanese culture, including the tea ceremonies and the historicaltemples. She mentions that she enjoys learning about the customs and the rich history of the country.15.You will hear a conversation between two students, Alice and Bob, discussing their weekend plans. Listen carefully and answer the question.Question: What does Alice plan to do on Saturday?A. Go shopping with her friends.B. Visit a museum with Bob.C. Stay at home and read a book.Answer: BExplanation: In the conversation, Alice mentions that she wants to visit the museum with Bob on Saturday, which makes option B the correct answer.16.You will hear a news report about a new study on climate change. Listen carefully and answer the question.Question: According to the news report, what is the main finding of the study?A. The climate is not changing at all.B. The effects of climate change are exaggerated.C. The study shows a direct link between greenhouse gas emissions and rising temperatures.Answer: CExplanation: The news report clearly states that the study has found a direct link between greenhouse gas emissions and rising temperatures, making optionC the correct answer.17.Listen to the following conversation between two friends and answer the question.A: Hi, John! How was your weekend?B: Oh, it was great! I went hiking with my friends in the mountains.A: That sounds fun! Did you see any interesting animals?B: Yes, we saw a few deer and a couple of wild turkeys.How many animals did John and his friends see?Answer: 3Explanation: In the conversation, John mentions that they saw “a few deer anda couple of wild turkeys,” whic h totals to 3 animals.18.Listen to the following dialogue between a student and a teacher and choose the best answer.Student: Professor, can you explain the difference between a noun and a verb? Teacher: Sure, a noun is a word that names a person, place, thing, or idea, while a verb is a word that shows action, occurrence, or state of being.Which of the following is a verb?A) AppleB) WalkC) HappyD) SchoolAnswer: BExplanation: In the dialogue, the teacher defines a verb as a word that shows action, occurrence, or state of being. Among the given options, “walk” is an action word and thus a verb.19.You will hear a short conversation between two students, discussing their weekend plans. Listen carefully and choose the best answer to the question that follows.Question: What does the male student plan to do on Saturday morning?A. Go shopping.B. Study for the exam.C. Watch a movie.Answer: BExplanation: The male student mentions that he has to study for the exam on Saturday morning, so the correct answer is B.20.Listen to a short news report about a new technology being developed. After hearing the report, answer the question that follows.Question: What is the main purpose of the new technology?A. To improve communication.B. To save energy.C. To enhance security.Answer: AExplanation: The news report states that the new technology is designed to improve communication, so the correct answer is A.二、阅读理解（30分）Passage:In the small coastal town of Seabreeze, the local library, known as the “Coral Cove Library,” has been a hub of community life for decades. The library, which was built in the 1950s, has faced many challenges over the years, including budget cuts and aging infrastructure. However, the community has rallied around the library, organizing fundraising events and volunteer programs to keep it operational.One of the library’s most cherished collections is its rare book room, which contains hundreds of first edition books and manuscripts that date back to the 18th and 19th centuries. The room is kept locked to protect the delicate books, and only a few staff members have keys. The rare book room has been a source of pride for the library and has attracted scholars and book lovers from around the world.Last year, the library faced an unexpected challenge when a group of vandals targeted the rare book room. The vandals broke into the library late at night and damaged several of the most valuable books. The incident was reported to the local police, and an investigation was launched. The library board decided to increase security measures to prevent future incidents.Despite the setback, the library continues to thrive. The community holds weekly storytimes for children and book clubs for adults. The library also hosts workshops and lectures on various topics, including history, art, and technology.The library’s efforts to engage with the community have been well-received, and attendance at events has been on the rise.Questions:1.What is the main purpose of the passage?A. To describe the history of the Coral Cove Library.B. To discuss the challenges faced by small town libraries.C. To highlight the importance of rare books in libraries.D. To explain the impact of community support on a local library.2.According to the passage, how did the community respond to the damage to the rare book room?A. They held a protest against the vandals.B. They donated money to replace the damaged books.C. They organized a cleanup crew to repair the library.D. They increased security measures and reported the incident to the police.3.What is the outcome of the library’s efforts to engage with the community?A. Attendance at events has decreased.B. The library has been closed due to budget cuts.C. The library has seen an increase in attendance at events.D. The library has lost interest in hosting community events.Answers:1.D2.D3.C三、完型填空（15分）Complete the following passage by choosing the most appropriate words or phrases from the list provided.In the small town of Willow Creek, there was once a [1] library that stood at the heart of the community. The library was more than just a place to borrow books; it was a hub of [2] and learning. Every day, people of all ages would come to [3] books, discuss current events, and share stories.One day, the town faced a crisis. The library’s [4] funds were running low, and it was in danger of closing. The townspeople were [5] about the future of the library. They organized a series of fundraising events, from bake sales to charity auctions, and the community came together to save their beloved library.1.A) bustling B) ancient C) struggling D) hidden E) charming2.A) arguments B) controversies C) excitement D) conversations E) solitude3.A) read B) write C) watch D) listen E) explore4.A) annual B) operational C) research D) monetary E) historical5.A) indifferent B) excited C) anxious D) amused E) indifferentAnswer:1.C) struggling2.D) conversations3.A) read4.D) monetary5.C) anxious四、语法填空题（本大题有10小题，每小题1分，共10分）1、Insert the correct form of the verb in brackets.The students (study)________very hard for their exams next month.Answer: studyExplanation: The present simple tense is used here to describe a habitual action. Since the subject “the students” is plural, the verb does not change form.2、Choose the appropriate preposition to fill in the blank.She was surprised________the gift she received from her friend.a)byb)withc)atd)toAnswer: byExplanation: The correct preposition to use after “surprised” is “by” when referring to the cause of the surprise. “Surprised by” indicates that the gift was the source of the surprise.Make sure to review these examples with your specific curriculum guidelines and adjust as necessary for your students’ level and learning objectives.3、The committee______(be) divided on the question of whether to fund the new project.•Answer: is•Explanati on: The subject “the committee” is treated as a singular entity, so we use the singular form of the verb “to be”, which is “is”. Even though a committee consists of multiple people, it’s often considered as one unit in English grammar.4、She will not go to the party unless she______(invite) personally.•Answer: is invited•Explanation: In this sentence, we need to use the passive voice because the focus is on the action (being invited) rather than who is performing the action. The correct form here is “is invited” to match with the third person singular subject “she”.请确保在实际的教学或测试环境中根据学生的水平适当调整题目的难度。
增设诊疗科目可行性研究报告范文
增设诊疗科目可行性研究报告范文英文回答：Feasibility Study Report on the Addition of Diagnostic and Treatment Subjects.Introduction:In this feasibility study report, we will examine the possibility of adding new diagnostic and treatment subjects to our medical facility. The purpose of this study is to assess the potential benefits and challenges associatedwith the expansion of our services. By conducting athorough analysis, we can make informed decisions regarding the feasibility of introducing new medical specialties.Market Analysis:To determine the viability of adding new diagnostic and treatment subjects, we must first analyze the market demand.This involves studying the current healthcare landscape, identifying gaps in services, and understanding the needsof our target patient population. By conducting surveys and interviews, we can gather valuable insights into the demand for specific medical specialties.For example, let's consider the increasing prevalenceof chronic diseases such as diabetes and cardiovascular conditions. By introducing an endocrinology department, we can cater to the growing number of patients requiring specialized care for these conditions. This not only meets the demand but also allows us to tap into a niche market, potentially attracting more patients and increasing revenue.Operational Considerations:In addition to market analysis, it is crucial to evaluate the operational aspects of introducing new diagnostic and treatment subjects. This includes assessing the availability of qualified medical professionals, necessary equipment, and infrastructure requirements. Furthermore, we need to consider the impact on existingdepartments and potential synergies with the new subjects.For instance, if we decide to add a dermatology department, we need to ensure that we have dermatologists with the required expertise. Additionally, we need to invest in specialized equipment and create dedicated spaces for dermatology consultations and treatments. By carefully evaluating these operational considerations, we can determine the feasibility of introducing new subjects without compromising the quality of existing services.Financial Implications:The financial aspect is a critical factor in assessing the feasibility of adding new diagnostic and treatment subjects. We need to evaluate the potential return on investment, considering the costs associated with hiring additional staff, acquiring new equipment, and marketing the new services.To illustrate, let's suppose we plan to introduce a fertility clinic. While there may be a significant initialinvestment in fertility treatment equipment and hiring fertility specialists, the demand for such services is high, and the potential revenue generation can outweigh the costs. By conducting a thorough financial analysis, we can determine the profitability and sustainability of the proposed expansion.Conclusion:In conclusion, the feasibility study on adding new diagnostic and treatment subjects involves conducting a comprehensive market analysis, evaluating operational considerations, and assessing financial implications. By carefully examining these factors, we can make informed decisions about the viability of expanding our medical facility's services. It is essential to consider the market demand, operational requirements, and financial aspects to ensure the successful integration of new specialties into our healthcare facility.中文回答：关于增设诊疗科目的可行性研究报告。
目标产品概述
Guidance for Industry and Review StaffTarget Product Profile — A Strategic Development Process ToolDRAFT GUIDANCE行业与评审员指南目标产品概述——战略研发过程的工具草案This guidance document is being distributed for comment purposes only.本指南文件的发布仅供征求意见之用。
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.有关本草案文件的意见和建议应在联邦注册公布本草案生效之日起60天内递交。
将意见递交至食品药品监督管理局档案管理部（HFA-305），地址为：5630 Fishers Lane, rm. 1061, Rockville, MD 20852。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
DEVELOPMENT REPORT - New Treatment Sleeping Sickness
Broadcast date: 1-4-2010 / Written by June Simms
From /voanews/specialenglish/ This is the VOA Special English Development Report. The World Health Organization is using a new combination of drugs to treat human African trypanosomiasis disease, also known as sleeping sickness. The drugs nifurtimox an eflornithine will be given out in Uganda and the Democratic Republic of Congo. Officials from the Drugs for Neglected Diseases Initiative say the new treatment has fewer side effects. It is also more effective and less costly than the drugs traditionally used. In addition, the new treatment reduces the number of injections needed. And it shortens the amount of time patients must spend in the hospital. Sleeping sickness threatens millions of people in thirty-six countries in Africa. Most live in poor rural areas. The disease is caused by the trypanosoma parasite. It is spread to humans through the bite of infected tsetse flies. Common signs of sleeping sickness include fever, headaches, extreme tiredness and pain in the muscles and joints. Early identification of the disease may be difficult because many infected people do not show any immediate symptoms. Over time, the parasites invade the central nervous system. The disease causes sleep disorders, mental confusion, personality changes, speech problems, seizures and coma. If left untreated, sleeping sickness kills. The World Health Organization estimates that about sixty thousand people are currently infected with the disease. It develops in two different forms. Trypanosoma gambiense is responsible for ninety percent of the reported cases of sleeping sickness. People infected with this form may develop the disease over many years without any major symptoms. The disease develops more quickly over a few weeks or months in people infected with trypanosoma rhodesiense. Until now the drug melarsoprol was used to treat patients in the advanced stage of sleeping sickness. But the drug requires many painful injections several times a day for several weeks. It also causes bad side effects, some of which can be deadly. In Uganda, a new study has confirmed earlier research linking the spread of sleeping sickness to infected farm animals. The writers of the study have called for stronger rules requiring cattle to be treated before being sold at market. The study was published in the Public Library of Science. And that's the VOA Special English Development Report, written by June Simms. I'm Steve Ember.