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oe 的final preproduction review

oe 的final preproduction reviewOE 的final preproduction reviewIntroduction:The final preproduction review for a project is a critical stage in the development process. It allows the team to assess the progress made, identify any potential risks or issues, and make necessary adjustments before moving into the production phase. In this article, we will discuss the key aspects of OE's final preproduction review, focusing on the important steps taken during this process.Step 1: Team assessment:The first step in the final preproduction review is to assess the team's overall performance. This involves analyzing their ability to meet deadlines, work collaboratively, and communicate effectively. The team leader should review each member's contribution and identify any areas needing improvement or additional support. This step ensures that the team is aligned and ready for the next phase.Step 2: Prototype evaluation:The second step is to evaluate the prototype developed during the preproduction phase. This involves conducting extensive testing to ensure the product's functionality, performance, and reliability. The team should pay attention to user feedback and address any issues or bugs identified. This step ensures that the prototype meets the requirements and expectations set forth in the project plan.Step 3: Risk assessment:During the final preproduction review, it is crucial to carry out a comprehensive risk assessment. This involves identifying potential risks that may hinder the success of the project. The team should analyze factors such as technology limitations, resource availability, and market competition. By understanding and addressing these risks, the team can reduce the likelihood of failure and develop appropriate mitigation strategies.Step 4: Budget and timeline evaluation:Another crucial aspect of the final preproduction review is evaluating the project's budget and timeline. The team shouldreview the estimated costs and compare them with the actual expenses incurred during the preproduction phase. Any deviations should be analyzed and appropriate adjustments made. Additionally, the timeline should be reviewed to ensure it remains realistic and achievable. This step ensures that the project remains within budget and is delivered on time.Step 5: Stakeholder feedback:As part of the final preproduction review, it is important to gather feedback from stakeholders. This includes key decision-makers, clients, and end-users. The team should organize meetings or surveys to collect their opinions and suggestions. Stakeholder feedback helps the team understand if their expectations are being met and if any modifications are required. It also allows for better alignment between all parties involved in the project.Step 6: Documentation and planning:Lastly, the final preproduction review involves reviewing project documentation and planning for the production phase. The team should ensure that all necessary documents, such as designspecifications, user manuals, and testing procedures, are complete and accurate. They should also establish a clear plan for the production phase, including resource allocation, task assignments, and deadlines. This step ensures that everyone involved in the project has a shared understanding of the tasks ahead.Conclusion:The final preproduction review is a critical stage in the development process of any project. It allows the team to assess their performance, evaluate the prototype, identify potential risks, and gather stakeholder feedback. By following these steps and making necessary adjustments, the team can ensure a smoother transition into the production phase. This ultimately increases the chances of delivering a successful outcome and meeting the project's objectives.。

finalreport基因组数据格式介绍

"finalreport" 是一种常用的基因组数据格式，用于存储和共享基因组测序结果。

它通常用于描述单个样本或个体的基因组信息，包括基因型、基因变异信息和其他相关数据。

Finalreport 格式是一个表格文件，保存为文本文件（通常是以 .txt 或者 .csv 为扩展名）。

它的结构一般包含以下列：
1. Sample ID: 样本的唯一标识符或名称。

2. SNP Name: 单核苷酸多态性（SNP）的名称或标记符。

3. Allele1 - Top: 参考基因型的第一等位基因。

4. Allele2 - Top: 参考基因型的第二等位基因。

5. GC Score: 基因型质量评分。

6. Allele1 - Forward: 正向测序的第一等位基因。

7. Allele2 - Forward: 正向测序的第二等位基因。

8. Allele1 - Top: 反向测序的第一等位基因。

9. Allele2 - Top: 反向测序的第二等位基因。

10. X: 基因型的概率（用于对目标位点进行质量评估）。

此外，文件中可能还包含其他与样本、位点或基因相关的列，例如位点坐标、基因型频率等。

具体的列名和数据内容可能会因研究设计和实验目的的不同而有所变化。

Finalreport 格式是一种常用的基因组数据格式，在基因组研究、个体基因分型、SNP分析等领域得到了广泛的应用。

通过这种格式，研究人员可以方便地存储、处理和共享基因组数据。

dpfoafinal

Table of ContentsPart 1. Overview InformationPart 2. Full Text of the AnnouncementSection I. Funding Opportunity DescriptionSection II. Award InformationSection III. Eligibility InformationSection IV. Application and Submission InformationSection V. Application Review InformationSection VI. Award Administration InformationSection VII. Agency ContactsSection VIII. Other InformationPART 1. OVERVIEW INFORMATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESFederal Agency Name: Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: Paul Coverdell National Acute Stroke Program Announcement Type:•New – Type 1Agency Funding Opportunity Number: CDC-RFA-DP12-1203Catalog of Federal Domestic Assistance Number: 93.283 Centers for Disease Control and Prevention Investigations and Technical AssistanceKey Dates:To receive notification of any changes to DP12-1203 return to the synopsis page of this announcement at: and click on the “Send Me Change Notification Emails” link. An email address is needed for this service.Letter of Intent Deadline Date: April 2, 2012Application Deadline Date: May 2, 2012, 11:59pm U.S. Eastern Standard Time Potential applicants may participate in a conference call for information on this Funding Opportunity Announcement (FOA). The conference call will be conducted by the Division for Heart Disease and Stroke Prevention. The call will be held within 30 days from the date of publication of this funding opportunity. Date of the call will be postedon the CDC, Division for Heart Disease and Stroke Prevention website/dhdsp/programs/stroke_registry.htm within 10 days after the date of publication. Call number for the call is 1-800-857-3853; passcode 8582854. CDC Telecommunications for the hearing impaired or disabled is available at TTY 1-888-232-6348.Additional Overview Content:Executive Summary:The Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Division for Heart Disease and Stroke Prevention (DHDSP) announces the opportunity to apply for funds to support and strengthen the capacity and leadership of state health department’s heart disease and stroke prevention programs by improving acute stroke treatment and outcomes through the implementation of Paul Coverdell Acute Stroke Registries. This competition is limited to State Health Departments including the District of Columbia. Up to $3,900,000 is available through this cooperative agreement to fund eight to twelve awards ranging from a minimum of $275,000 to a maximum of $500,000. The anticipated date of award is on or about June 30, 2012 for a 12-month budget period within a project period of up to three years. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and subject to the availability of funds. Matching funds are not required.CDC has funded the Paul Coverdell National Acute Stroke Registry since 2001 to improve the quality of acute stroke care and health outcomes for acute stroke patients. Program activities will address the continuum of care from onset of stroke through rehabilitation and recovery, focusing on health systems change and community and clinical linkages. This FOA offers 3 funding categories; applicants are allowed to submit only one application (i.e. select and apply for only one funding category for the application). Program activities will work to improve disease management across clinical settings including improving:•the quality of emergency medical services for acute stroke,•the quality of handoff from EMS to hospitals,•the quality of acute stroke care in hospitals, and•the transition from hospital to home or rehabilitation and from stroke specialist care to primary care provider.This program announcement provides support for the development of strategicpartnerships for improving stroke care at the state level and thus encouragesimplementation of quality improvement activities with EMS, hospitals, stokespecialists, and rehabilitation facilities.Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for Chronic Disease Prevention and Health Promotion:•Reduce the age-adjusted annual rate per 100,000 population of stroke deaths (GPRA, HP-HDS3).•Increase the age-adjusted proportion of persons age 18+ with high blood pressure who have it controlled (GPRA, HP-HDS12).This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.PART 2. FULL TEXTI.FUNDING OPPORTUNITY DESCRIPTIONStatutory AuthorityThis program is authorized under Section 317 of the Public Health Services Act (PHS Act), 42 U.S.C. 247b(k)(2) as amended.BackgroundOver 130,000 people in the United States die of stroke annually, accounting for one in 18 deaths in the United States. On average, every 4 minutes someone dies of a stroke. Over 795,000 people have a stroke annually at a cost of nearly $54 billion each year. Four out of every five persons having a stroke have hypertension and currently fewer than half ofall persons diagnosed with hypertension have it controlled. In 2001, Congress directed the Centers for Disease Control and Prevention to establish the Paul Coverdell National Acute Stroke Registry (PCNASR) to improve stroke care for people experiencing a stroke. CDC, The Joint Commission, and the American Heart are working together to improve acute stroke care through Get With The Guidelines – Stroke, and the Paul Coverdell National Acute Stroke RegistryPatient safety and improvement of healthcare services are key components of the Affordable Care Act and the National Quality Strategy for healthcare. Goals of the National Quality Strategy for healthcare that are aligned with the goals and mission of the Paul Coverdell National Acute Stroke Program include:•Making care safer by reducing harm caused in the delivery of care.•Ensuring that each person and family is engaged as partners in their care.•Promoting effective communication and coordination of care.•Promoting the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease.PurposeThe purpose of the program is to support and strengthen state health departments’ heart disease and stroke prevention programs to develop stroke systems of care that span the continuum of care working to improve the overall quality of stroke care within states through health systems change and surveillance and epidemiologic activities. This initiative will build on the work begun and lessons learned since the inception of the Paul Coverdell National Acute Stroke Registry(/dhdsp/programs/stroke_registry.htm), hereafter referred to as ‘the Program’. This initiative will develop collaboration among state health departments, emergency medical services, hospitals, rehabilitation facilities, stroke care providers, other health care providers, other stakeholders focusing on improving stroke care, and the CDC. Grantees funded under this FOA will work collaboratively with public and private partners to implement components of an integrated stroke system of care with a strong focus on quality improvement and effective and efficient transitions of care for stroke patients. Efforts in surveillance and quality improvement will focus on the particular elements of the continuum of stroke care as depicted in Figure 1, beginning with onset ofPre-Event Event Post-Event stroke (‘Event’): EMS, acute care, rehabilitation, secondary prevention, telemedicine, and transitions of care.Figure 1. Components of the Stroke Care SystemGoalsMeasureable outcomes of the program will be in alignment with the following performance goals which are part of the overall mission of the Division for Heart Disease and Stroke Prevention:• To reduce death and disability due to heart disease and stroke and eliminate disparities in care.• Increase quality of EMS care for possible stroke patients through:o The use of pre-hospital notification of possible stroke patients by EMS.o The use of pre-hospital stroke scale by EMS.o The use of thrombolytic check list by EMS where appropriate.o Blood glucose determination in possible stroke patients.o D ocumentation of time of discovery of patient’s symptoms and timepatient was last known to be well.• Improve the transition of care from EMS to hospital ED staff :o Through the use of effective communication protocols by EMS to hospital staff and communication from hospital to EMS on patient’s final diagnosis.o Through the use of a data collection mechanism to link EMS data withhospital data for quality improvement purposes, to the extent possible withrespect to HIPAA guidelines.•Improve the quality of acute and subacute hospital stroke care through adherence to established guidelines and endorsed quality measures (e.g. Brain AttackCoalition recommendations for Primary Stroke Centers and ComprehensiveStroke Centers, National Quality Forum (NQF) endorsed stroke measures,American Heart Association’s Get With The Guidelines – Stroke measures andgoals, CDC and CMS patient safety goals and priorities).•Improve the transition of care from hospital to rehabilitation, home and primary care provider, or long-term care facility.o This area is poorly developed in the literature. It is expected that the grantee will partner with stroke care providers and rehabilitationspecialists and primary care providers to develop, implement and monitorquality improvement activities and protocols to improve adherence tosecondary prevention, improve receipt of, and patient and caregiverunderstanding of, ongoing post-stroke care; and reduce the likelihood ofreadmissions for complications after stroke (including but not limited topressure sores, falls, aspiration pneumonia, catheter associated urinarytract infections, venous thromboembolic events (VTE) events, and adversedrug events from warfarin and other anticoagulants).Approach•This FOA offers three (3) Categories of funding:o Category A: In-hospital stroke quality improvement component.o Category B: Implement Category A activities and one enhanced activities: ▪Category B – EMS (emergency medical services): EMS (andtransition from EMS to hospital) and in-hospital stroke qualityimprovement components.▪Category B – TOC (transition of care): In-hospital stroke qualityimprovement and post-hospital transitions of care to rehabilitationor home components.o Category C: Implement Category A and both Category B enhanced activities (EMS and TOC).All grantees, regardless of category, are expected to leverage and build upon cross-cutting functions of leadership, policy, communications, epidemiology, surveillance, and evaluation and to ensure that policies and programmatic strategies create synergy and sustainability across multiple programmatic areas as applicable to building or enhancing state stroke systems of care.Program ImplementationRecipient ActivitiesRecipient activities for this program to be addressed within the project period of up to three (3) years are as follows. In some instances, category specific activities are specified; where no category is specified the activity applies to all categories (A, B, and C):I.Program Infrastructure, Staffing, Management and SupportTo be completed by year one:Category A:•Appropriate leadership with necessary skills in place to manage the program.•Develop plan to receive data from hospitals engaged in acute stroke quality improvement and begin receiving data from hospitals.•Transmit hospital care data to CDC each calendar quarter through CDC’s Secure Data Network, beginning not later than January 2013.Category B:•Implement all activities for Category A.•(EMS or TOC) Development of a state stroke care plan that encompasses the continuum of care from pre-hospital through rehabilitation, recovery, andsecondary prevention. If a plan is already in place, review existing plan andupdate as necessary. Submit plan with annual report.•(EMS or TOC) If state stroke care plan is already in place, it is expected that implementation of the selected components for this FOA will begin duringyear one.• (EMS) Establish a partnership with EMS to address improving coordinated stroke care.• (TOC) Establish a partnership with a rehabilitation specialist and transition coordinator to address improving coordinated stroke care. Document inannual report.Category C:•Complete all activities for Category A, Category B – EMS, and Category B - TOCTo be completed by year two:Category A•Develop a plan for sustainability of the program and submit with annual report.Category B•(EMS) Establish a plan for data linkage between selected components of the stroke care plan (EMS and Hospital).• (TOC) Establish a plan for data linkage between selected components of the stroke care plan (Hospital-Rehabilitation & Recovery).Category C:•Complete all activities for Category A, Category B – EMS, and Category B - TOCTo be completed by year three:•Attendance and participation at all CDC-sponsored trainings and/or meetings by at least two program staff in years that meetings are held.II.Reporting Requirements•Grantees will be required to submit an annual end of year report within 90 days of the end of each year of funding. CDC will develop the format for the report.•Grantees will be required to submit an annual continuation application for each year of continued funding. CDC will develop the format for the report. Provide a written report on sustainability of the program with the annual report.III. Fiscal management•Establish any necessary contracts, grants, or memoranda of agreement with key program partners to assure implementation of program activities.•Ensure that a sustainability plan is in place that leverages all resources available, including federal, state, and local resources.•Award contracts/grants and ensure efficiencies in program management resulting in minimal unobligated funds, accurate and timely submission offederal financial reports, and leveraging of resources.•Performance will be measured by evidence that the awardee performs a substantial role in carrying out project objectives and does not merely serve asa conduit for an award to another party or provider who is ineligible and thatfiscal system proactively tracks and monitors expenditures to ensureefficiencies in program management and leveraging of resources; reportingrequirements are met in a timely manner.IV.Partnership Development and Maintenance•Develop effective partnerships with existing stroke-related organizations, hospital systems, universities, and emergency medical services that willpromote a coordinated stroke system of care in your state.•Establish a plan for partnership development and maintenance that is consistent with any CDC MOUs with national partners.•Produce an annual written report on the effectiveness of the partnership with existing stroke-related organizations within your state.V.Data Collection•Establish a secure system to maintain any data collected that is capable of assessing the quality of collected information. The secure data system andcollected data should be in compliance with applicable HIPAA regulationsand secure all identifiable personal health information.•Implement and support the operation of a hospital-based stroke registry that collects information relevant to clinical evaluation, diagnosis, and treatment ofpatients presenting to the hospital with an admitting diagnosis of stroke ortransient ischemic attack, or presenting with an in-hospital stroke.•If implementing the EMS component: establish secure data collection to support quality improvement in EMS for acute stroke care.•If implementing the transition of care from hospital to rehabilitation or home component: establish a secure data collection system capable of documentingaspects of the transition of care that will serve as a basis for qualityimprovement activities•Data to be collected will be developed by CDC in association with American Heart Association’s GWTG-Stroke quality improvement program and withThe Joint Commission’s disease specific certification programs for stroke.•After 9/30/2013 or by the HHS ICD-10 compliance date (whichever is later), ICD-9-CM codes will not be accepted and must be updated to ICD-10-CMcodes.Performance MeasuresCategory A•Data collection should begin in year one.Maintain on-going hospital data collection of specified quality improvementdata.•Plan and implement a method to assess hospital case ascertainment and case selection for inclusion, as well as annual chart audits to ensure reliability ofdata.Category B•(EMS): Submit data on EMS care, which is co-developed by the grantee and CDC.•(TOC): Submit data on transition of care, which is co-developed by the grantee and CDC.•(EMS) Develop and implement a plan to assess hospital and EMS case reporting and reliability of data.•(TOC) Develop and implement a plan to assess transition of care data monitoring.Category C•Complete all activities for Categories A and B (EMS and TOC).VI.Quality Improvement•Develop and maintain a quality improvement program to increase the quality of care in all applicable program components. Program should be based onestablished QI principles and should support the reduction of hospital acquired conditions which stroke patients are most-likely to develop (aspirationpneumonia, catheter-associated urinary tract infections, venousthromboembolic disease, falls, pressure sores, and adverse drug events fromthrombolytic and antithrombotic medications).•The QI program should be data-driven – that is, the direction and activities of the QI program should be informed by needs as determined by relevant datacollected through this program.•The QI program should be reflective of the program goals as outlined in this FOA, and encompass all components intended for implementation.o Implement and evaluate interventions that support QI and evidence-based clinical practice guidelines for stroke care using system and policyapproacheso Report state progress in implementing specific intervention strategies and the impact on QI measures annually.o Provide objective assessment of hospital QI needs and develop and implement a plan to provide feedback to hospitals (and EMS for categoriesB and C) regarding QI initiatives and outcomes.o Demonstrate that QI efforts of Program are integrated with other state efforts for improving stroke care.Performance MeasuresTo be completed by year one:Categories A•Develop and implement a formal QI plan and revise annually as needed.Include the QI plan in all annual reports.Category B•(EMS) Implement interventions designed to impact the quality of care for EMS.•(EMS) Implement a quality improvement plan for the EMS component to improve the quality of care for acute stroke patients and submit plan with theannual report.•(TOC) Implement interventions designed to impact the quality of care transition from hospital to discharge setting.•(TOC) Implement a quality improvement plan for the TOC component to improve the quality of care for acute stroke patients and submit plan with theannual report.Category C•Complete all activities for Categories A and B (EMS and TOC).To be completed by years two and three:•Include a written report on the impact of intervention strategies over time on all selected QI interventions in the annual reports.•Include a report on the assessment of hospital QI needs and the feedback provided to hospitals regarding QI initiatives and outcomes in the annualreports.•Include a report on the integration of the Program with other state stroke efforts for improving stroke care in the annual report.VII.Performance Monitoring and EvaluationCDC may revise the existing evaluation requirements through an addendum to this notice, which could include additional recipient requirements for evaluation.•While performance monitoring is required for all activities, grantees should allocate resources to implement a process and outcome evaluation plan oftheir program. The evaluation activities should include measurement of reachand impact, and be designed with a methodology of sufficient rigor to informthe evidence base at the end of the project period and demonstrate whether ornot improvements in intended outcomes occurred, in part, due to contributionsof the program.•Develop a program logic model that provides a logical visual presentation of program inputs or resources, activities, outputs, and outcomes.•Develop a plan to evaluate program components and measure the reach and impact of the program. (refer to Evaluation Guide on Developing anEvaluation Plan available at/dhdsp/state_program/evaluation_guides/pdfs/evaluation_plan.pdf)•Use process and performance monitoring data to document steps taken to implement changes by describing successes, barriers, and challenges. Use thisinformation to inform ongoing program improvement and midcoursecorrections.•Collaborate with CDC to evaluate and assess program outcomes, reach and impact.•Identify relationships between proposed outcomes measures and proposed activities in the implementation plan.•Participate in the planning of nationally coordinated evaluation activities planning.•Develop (or contribute) and disseminate at least one unique document created for the program stakeholders or community-at-large, including briefing update,report, poster, presentation or manuscript.•Evaluate selected components.a)Category A: Evaluate the effectiveness of the quality improvementinterventions implemented.b)Category B-TOC and Category C: Evaluate the transition of careprotocols implemented from hospital to home.c)Category B-EMS and Category C: Evaluate the EMS QI program andtransition from EMS to hospital.Performance MeasuresTo be completed by year one:•By the end of 6 months, develop a program logic model that provides a logical visual presentation of program inputs or resources, activities, and outcomes;•Submit to CDC an evaluation plan that is directly tied to major components of the final implementation plan and proposed timeline. Performance will beassessed by evidence of a CDC approved evaluation plan.•Provide a description of plans for using evaluation findingsTo be completed by year two:•Submit updated logic models and evaluation plans annually.•Implement formal program evaluation and report on progress of evaluation activities, findings, and the reach and impact of the program to CDC by theend of the year.To be completed by year three:•Submit updated logic models and evaluation plans annually.•Evaluate the stroke care continuum components (Category A, B, and C) selected for systems change and/or quality improvement through integrationand quality improvement interventions for their impact in year 3.•Implement formal program evaluation and report findings to CDC in the annual report, including reach and impact of the program.•Develop or contribute to the development of one unique document to disseminate results of evaluation.CDC ActivitiesIn a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program are as follows:•Provide ongoing consultation and technical assistance:o For effective program planning and management through conference calls, site visits, and meetings for grantees.o In the development of case definitions, methods of case finding, and standard data items to be used by grantees and reported to CDC, o To provide secure data transfer protocols for transfer of stroke registry information from grantees to CDC.o On the development and implementation of evaluation activities.•Collaborate in establishing or endorsing program standards for completeness, timeliness and accuracy of data.•Collaborate with grantees on data collection, data linkage quality improvement indicators and interventions and minimal data collection for the program.•Collaborate with external partners too Develop and maintain quality improvement performance measures.o Develop and implement data abstraction training.o Develop and implement data validation procedures.o Develop and implement quality improvement assistance for hospitals, EMS, and other stakeholders.II. AWARD INFORMATIONType of Award: Cooperative Agreement.Award Mechanism: U58: Chronic Disease Control Cooperative AgreementFiscal Year Funds: 2012Approximate Current Fiscal Year Funding: $ 3,900,000Approximate Total Project Period Funding: $ 11,700,000 (This amount is an estimate, and is subject to availability of funds.) This amount includes direct and indirect costs. Anticipated Award Date: June 30, 2012Budget Period Length: 12 monthsProject Period Length: 3 years (36 months)Throughout the project perio d, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government. This proposed three-year cooperative agreement may be ended early (prior to the full three year project period has elapsed) in the event of changes in Congressional funding levels and/or public health priorities.Category A (In-hospital stroke quality improvement component)•Approximate Number of Awards: 4-6•Approximate average award: $ 275,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.) •Ceiling of individual award: $ 300,000 (this ceiling is for the first 12-month budget period, and includes both direct and indirect costs).Category B (In-hospital stroke quality improvement component and one enhanced activity)•Approximate Number of Awards: 4-6•Approximate average award: $ 350,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)•Ceiling of individual award: $ 400,000 (This ceiling is for the first 12-month budget period, and includes both direct and indirect costs).Category C (In-hospital stroke quality improvement component and both enhanced activities)•Approximate Number of Awards: 1•Approximate average award: $ 500,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)Ceiling of individual award: $ 600,000 (This ceiling is for the first 12-monthbudget period, and includes both direct and indirect costs).III. ELIGIBILITY INFORMATIONEligible ApplicantsEligible applicants that can apply for this funding opportunity are listed below: •State governments (this includes the District of Columbia)Limited Eligibility:Eligibility is limited to state health departments (to include the District of Columbia) with heart disease and stroke prevention programs for this cooperative agreement.State health departments are the only agencies who are uniquely positioned to develop strong state level task forces to develop these stroke systems of care that can be used to focus on an comprehensive approach to improving quality of care at all points along the continuum of care that will have the largest reach and impact on decreasing morbidity and mortality from stroke, reducing disparities in the delivery of care, and improving outcomes.This uniqueness of effort is demonstrated by a number of attributes.State health departments have effective collaborations in place with strategic public and private partners at the national, regional, and state level, state hospital associations, state physician associations, quality improvement organizations, emergency medical services agencies, and others. Established and effective relationships forged while developing and implementing heart disease and stroke prevention programs provides immediate focus and leverage of resources for the program activities.State level governmental agencies also have the recognized leadership in heart disease and stroke prevention necessary to positively affect systems change for stroke systems of care. Additionally, these heart disease and stroke leaders are the acknowledged leaders。

Final_Test_-_6-1-2012

DC Component
The part of the spectrum that is mainly responsible for the detail
The part of the spectrum where noise can be found
The part of the spectrum that is responsible for the general structure
(a) (5 Points)Important in the analysis of any image is the Fourier Transform.Sketch the Fourier spectrum ofanimage and label (标记) the following parts within this spectrum:
Good luck, and enjoyБайду номын сангаасyourWinterHoliday!!
(8points, each mistake is 1/2 point less)
Translate the following words from English to Chinese and from Chinese to English
Read the questions CAREFULLY! Many mistakes can be prevented by reading the question carefully, as the saying goes: “A good question is half the answer!”
The part of the spectrum where the high frequencies can be found

Internal Qetion Final

GCG Greater China Region Formation Q&AInternal Questions and Answers1. Why is this change being made?This announcement represents a significant commitment by Kodak to growing the GCG business in China. Through the formation of the Greater China Region,Kodak is providing strong organizational resources and the leadership to supportgrowth in China’s commercial graphics industry. In terms of organization, Greater China will have a full spectrum of management and support. In the area of senior leadership, we will be joined by a new Chairman and Executive Director, Mr.Haixiang Shen, a well known and highly influential leader in China’s printingindustry.2. Will there be a change to our business nature and scope?This announcement does not change the nature of the GCG business. It enables a more rapid growth of the GCG business in China and Asia. This new structureallows the GCG to bring our customers across Asia more focused solutions.3. Why is the GAR region being split in two?The formation of the Greater China and INSEAN Regions enables the GCG tohave a full spectrum of resources to pursue business growth across Asia. Chinaand other markets provide superb business growth opportunities, which will besupported by world class organizational resources and product solutions.4. What is the growth potential for the GCG business in China?Graphic communications is one of many industries growing at double digit ratesin China. While Kodak is already in a strong position in this market, the newstructure enables us to strengthen our industry leadership and participate morefully in the growth anticipated for the industry.5. How will reporting lines within the organization change?Mr. Shen, Chairman and Executive Director, Greater China Region, will reportdirectly to Jeff Jacobson, Chief Operating Officer. Paul Loh, Managing Director, Greater China Region will report to Andrew Copley, Managing Director, GlobalSales and Operations, and to Mr. Shen. Garron Helman, Managing Director,INSEAN (including Australia & New Zealand, India, South Korea and Southeast Asia), will continue to report to Andrew Copley. The GCG’s Managing Directors in the INSEAN countries will continue to report to Mr. Helman.6. How will the responsibilities of existing GCG managers change as a result of this announcement?Generally, responsibilities will not change as a result of this announcement,except in two areas. First, some reporting lines will change as noted above.Second, the functions within GCG (including finance, HR, operations andmarketing) are being reviewed, and additional announcements will soon be issued about how those functions will support the Greater China and INSEAN Regions.7. How will this affect integration of the GCG entities in GCR and INSEAN?The integration process is already well underway with significant progress infinance, human resources and operations. This process will continue as planned to integrate financial reporting, HR administration and management systems across the GCG entities. This announcement will not significantly affect the timetablefor that integration activity in 2006.8. How will T&IS fit into the new organization?Lois Lebegue will continue to be responsible for sales and marketing activities of T&IS in both the Greater China and INSEAN Regions. Mr. Lebegue will workclosely with Mr. Shen, Paul Loh and Garron Helman to identify synergies andmeet customer needs across the region. Mr. Lebegue will also remain responsible for the T&IS businesses in Japan.9. Isn’t this j ust adding another layer of organization – against the corporate direction of “lean”?The formation of the two regions brings a stronger focus to the GCG’s business in China and across Asia. This announcement does not add layers to ourorganization. GCG management in Asia is lean and will remain so. The additionof Mr. Shen, supported by Paul Loh as Managing Director of the Greater Chinabusiness, contributes to our ability to lead the commercial graphics industry inChina.10. If support functio ns like finance, operations and HR are split in two, won’t that increase the cost burden of the organization and make it more difficult to deliver earnings to the company?The organization provides appropriate and effective support to both the GreaterChina Region and INSEAN teams. We will leverage existing resources to provide support in a lean and cost effective fashion, not simply doubling up back officesupport. We will announce details about the structure of support organizationssoon.11. Will there be further changes?We do not anticipate further changes in the GCG organization at this time.However, this announcement demonstrates Kodak’s commitment to move quickly and aggressively to match major market opportunities with organizational andleadership resources so that we can better serve customers in Asia and worldwide.12. How important is China to the worldwide GCG strategy?China is an extremely important market for Kodak in all of its businesses. Chinais a rapidly changing market, and Kodak is positioned to meet the evolving needs of Chinese customers.。

Optimization-final

Multi-Dimensional Selection
For multi-dimensional, there are two sets of methods which can be grouped by the use (or lack there-of) of the gradient. The gradient is the set of first partial derivatives for a function f and is represented as : f f f x ,..., x n 0
Two standard methods exist :
F(x) with global minimum D and local minima B and F
(a) Searching methods – Which find local extremes using several sets of values (Points) for each function variable then select the most extreme. (b) Iterative methods – Which select a single starting value (Point) and take “steps” away from it until the same Point is returned
– 2 Dimensions – triangle – 3 Dimensions - tetrahedron
Downhill Simplex Method, cont’d.
• Start with N+1 points • Move point where f is largest through opposite face of simplex

Final Report_Job Evaluation_A

得分清单
事业部／部门总部总部总部总部保鲜瓶袋奶常温牧业物流总部广州总部总部信息中心总部可的工业原料总部总部技术中心总部营养品总部总部光明松鹤保鲜黄油干酪可的保鲜总部保鲜总部技术中心保鲜岗位名称总裁行政副总裁运营副总裁技术副总裁总经理总经理总经理总经理总经理财务总监总经理市场总监人力资源总监信息总监战略发展总监总经理总经理主任(兼法律顾问) 首席研究员总经理采购总监总经理工程总监审计部总监总经理财务总监总经理副总经理兼商品总监市场部经理资产证券经理华北大区总经理全国重点客户经理质监部经理学生奶销售公司经理编号 23 24 25 26 41 45 47 57 61 1 50 15 7 70 29 66 49 19 28 72 10 78 12 27 48 33 76 67 38 2 42 18 71 43 C C C C C C C C C A C A A A A C C A A C A C A A C A C A A A A A A A 职能分类综合综合综合综合综合综合综合综合综合财务综合市场人力资源信息技术战略咨询综合综合行政战略咨询综合生产综合生产审计综合财务综合综合市场财务综合销售生产综合评估岗位总部：总裁总部：行政副总裁总部：运营副总裁总部：技术副总裁保鲜：总经理瓶袋奶：总经理常温：总经理牧业：总经理物流：总经理总部：财务总监广州：总经理总部：市场总监总部：人力资源总监信息中心：信息总监总部：战略发展总监可的：总经理工业原料：总经理总部：主任(兼法律顾问) 总部：首席研究员技术中心：总经理总部：采购总监营养品：总经理总部：工程总监总部：审计部总监光明松鹤：总经理保鲜：财务总监黄油干酪：总经理可的：副总经理兼商品总监保鲜：市场部经理总部：资产证券经理保鲜：华北大区总经理总部：全国重点客户经理技术中心：质监部经理保鲜：学生奶销售公司经理得分 985 965 965 895 875 875 875 875 875 870 865 860 860 860 845 840 805 805 800 800 765 765 760 735 735 735 725 725 715 705 695 695 695 690 职级 T2 T2 T2 T2 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 T1 MS2 MS2 T1 MS2 MS2 MS2 MS2 MS2 MS2 MS2

Final Presentation

Morris, Annie.
“Creating New Identities.” LitCrit series. Augustana College, Rock Island, Il. May 2009.
feminism, “is about taking women seriously and respectfully” and to, “reverse a pattern and history of not taking women seriously” (Parker 136-7). It is also not about being hypercritical men. It is about looking at the ways in which women and the feminine gender appear in literature and other medium (Parker). Because feminist criticism deals with gender portrayal, and
People often see feminist criticism as unreasonable and irrational. This, of course, is not true. It is also part of the basis of what feminist criticism is trying to do. According to Parker
Sources
Discovery Channel. Science of Sex Appeal. Discovery Networks. Video.
◦ Several years ago, the Discovery channel made a documentary to show everyday people the research done by social scientists on how people judge attractiveness and how they choose their partners. The researchers in The Science of Sex Appeal believe that beauty is universal, that what we find attractive is determined by evolution, and that what we find beautiful is shown by our genetics. They prove this by showing several different aspects people look at in determining sex appeal, such as the face, body shape, etc and then showing the experiments done as evidence. This was a very well done documentary; it presented the research in a way that was both informative and entertaining. The Science of Sex Appeal is a good documentary for anyone interested in learning more about universal standards of beauty or interested in research done on interpersonal relationships.

presentation100204-finalEN[1]

JA SOLAR INTRODUCTIONPresented by Market ing TeamApril 13, 2010OUR VISIONCOMPANY OVERVIEWJA Solar Holdings Co., Ltd. (JA Solar) develops, manufactures and markets high quality solar photovoltaic products to customers worldwide. On February 7, 2007, JA Solar completed a successful Initial Public Offering, raising $258 million in net proceeds to the company, and is listed on the Nasdaq under the symbol JASO.JA Solar's corporate headquarters are in Shanghai, China with manufacturing facilities in Ningjin, Hebei Province and in Yangzhou, Jiangsu Province. The manufacturing base in Ningjin was JA Solar's first production center, which began operations in March 2006, and achieved annual capacity of 425MW by the end of 2008. The Yangzhou operation began production in the second half of 2008 and hosts JA Solar's new R&D center with more than ten current production lines capable of 250MW solar cells output per year.JA Solar is committed to creating sustained value by harnessing the world's sunlight. The core values of JA Solar's philosophy are integrity, persistence and teamwork. It is JA Solar's earnest desire to excel in providing solar energy products to best serve society and the environment.OUR MISSIONCreating ValuesFor Employees, Customers,Partners, Shareholders, andCommunity!Energy & EnvironmentSustainabilityHarness Sunlight to Meet theWorld’s Energy DemandSocial ResponsibilityCreate and Promote SustainableEnergy SolutionsDedicating flaw less schedule to create the perfect.Cost-effectiveness makes us one of the most competent worldwide suppliers.Fulfill the promise of delivering the best product with stable quality.Enhance innovation to develop and apply leading technologies.COMMITTMENTCORE VALUES ⏹INTEGRITY⏹TEAMWORK⏹PERSISTENCEHISTORY & MILESTONEMay 2005Ningjin Jinglong Zhong’ao Solar Co., Ltd. was established with registerd capital of RMB60,000,000. In November, it was renamed JingAo Solar Co., Ltd. and the registered capitalwas increased to RMB 120,000,000.April 2006The first 25 MW solar cell production line of JA Solar started trial production.February 2007JA Solar Holding Co., Ltd. was listed on NASDAQ of the United States, and successfully completed the second offering in October.December 2007The headquarter of JA Solar moved into JA Plaza –the brand new office was put intoservice.February 2008JA Solar (Yangzhou) was laid a foundation, Phase I occupies 16.36 hectares with full capacity of 200MW. A total amount of $98 million is invested in Phase I for solar cell production.MANAGEMENT TEAMBaofang JinExecutive Chairman and Chairman of the Board of DirectorsMr. Baofang Jin is the executive chairman and chairman of JA Solar; he has been the chairman of the board of directors since May 2005.Mr. Jin has also been the chairman of the board of directors and chief executive officer of Jinglong Group since 2003.Mr. Jin currently serves as vice-chairman of the Chinese People's Political Consultative Conference of Ningjin County, vice president of Hebei Chamber of Commerce, vice chairman of Hebei Association of Entrepreneurs, executive chairman of Hebei Information Industry Association, chairman of Electronic Information Materials Sub-Association of Hebei Information Industry and Informatization Association, etc..Mr. Jin has served in several positions during his career, including director of executive office of Ningjin County Agricultural Equipment Bureau, manager of Ningjin County Agricultural Equipment Supply Company, director general and secretary of the Party committee of Ningjin County Bureau of Power, secretary of the Party committee of Ningjin County Power Supply Company as well as other posts.Mr. Jin was awarded National Model Worker, Model Worker of Hebei Province, National "Wuyi" Work Medal, Outstanding Entrepreneur of Hebei Province, etc., and was the deputy to the 10th and 11th National People's Congress.Mr. Jin holds an associate's degree from Hebei Broadcast and Television University in China.MANAGEMENT TEAMPeng FangChief Executive OfficerDr. Fang Peng was appointed Chief Executive Officer in January 2010.Dr. Fang joins JA Solar with more than 20 years of executive management experience with leading global technology companies in the solar and semiconductor industries in both the U.S. and China.Dr. Fang was president of Best Solar Co., Ltd., where he turned a start-up company into an internationally known solar module company in just 18 months. Dr. Fang was formerly president of Huahong NEC, one of the largest semiconductor foundries in China.Dr. Fang has also held various technology and management positions at Applied Materials and AMD in the U.S.Dr. Fang received his Ph.D and MSEE degrees from the University of Minnesota. He was also a postdoctoral research fellow at the EECS Department of UC Berkeley. Dr. Fang was chairman of the IEEE Electron Devices Society, Santa Clara Valley Chapter.MANAGEMENT TEAMJian XieChief Operating OfficerMr. Jian Xie was appointed as Chief Operating Officer in January 2010. He has been the director of board since August 2009.Since joining JA Solar in April 2006, Mr. Xie has served in such capacities as the company's director of corporate finance, director of investor relations, assistant to the chief executive officer, secretary of the board of directors and vice president of Sales.Prior to joining JA Solar, Mr. Xie worked in the investment banking department of Ping'an Securities Co., Ltd., and as an associate in the investment department at Dogain Holdings Group Co., Ltd.Mr. Xie received his master's degree in finance from Guanghua School of Management at Beijing University in 2004.MANAGEMENT TEAMAnthea ChungChief Financial OfficerMs. Chung was appointed Chief Financial Officer in January 2009.She has more than 16 years of financial management experience at public and private companies, including most recently the chief financial officer position at Solar Enertech Corp., a public company that manufactures solar cells and solar modules in Shanghai and Menlo Park, Calif. There she had full responsibility for finance, investor relations and legal activities. She was also vice president and corporate controller at RAE Systems in San Jose, Calif. for three years prior to being CFO at Enertech. At RAE Systems, which manufacturers and sells gas detection equipment, she was responsible for all financial statements and SEC filings, and directed the company's finance teams in the United States and in eight international locations. She has also been corporate controller at TLZ Inc. in Mountain View, Calif., a maker of laser measurement tools. She began her career as an auditor at PricewaterhouseCoopers, where she rose from associate to audit manager in her eight years there.Ms. Chung earned her bachelor of science degree in accounting at Indiana University, and is a certified public accountant in California.MANAGEMENT TEAMYong LiuVice PresidentMr. Yong Liu was appointed vice president in August 2009.Mr. Liu has been general manager in charge of JA Solar's Yangzhou manufacturing site since he joined the company in July 2008.Mr. Liu has more than 15 years of operation management experience at semiconductor wafer and solar cell manufacturing facilities. Prior to joining JA Solar, he served as fab director at Semiconductor Manufacturing International Corporation (SMIC), responsible for running three 12-inch wafer foundry fabs, which were the most advanced wafer fabs in China. Mr. Liu had held various management positions in R&D and manufacturing since joining SMIC in 2001. Previously, Mr. Liu worked as deputy production manager at Wacker Siltronic Singapore.Mr. Liu received his master's degree in solid state chemistry and bachelor's degree in solid state physics from the University of Science and Technology of China in 1992 and 1990, respectively.MANAGEMENT TEAMBoping LiVice PresidentMr. Boping Li was appointed vice president in August 2009.Mr. Li served as vice general manager, manager of equipment department and other posts in JA Solar from March 2007 to October 2008Prior to joining JA Solar, Mr. Li worked as vice general manager at Nanjing FAB Technology Co., Ltd., and from September 2005 to May 2006, he was manager of the equipment division of China Sunergy Co., Ltd. (formerly CEEG (Nanjing) PV-Tech Co., Ltd (NPV)). Before that, Mr. Li served in several supervisor/project manager positions at Nanjing Huafei Colour Display System Co., Ltd. from 1993 to 2005. He began his career as an equipment engineer at Nanjing Color Picture Tube Co., Ltd. in August 1992.Mr. Li holds a master's degree in software engineering from East China Normal University and a bachelor's degree in radio technology from Zhejiang University.MANAGEMENT TEAMMing YangVice PresidentMr. Ming Yang was appointed vice president in January of 2009.Mr. Yang has more than six years of experience working as a Wall-Street buyside and sellside analyst, specializing in the renewable energy and semiconductor materials sectors. Most recently, Mr. Yang was an analyst covering the renewable energy sector at Coatue Management, a $2 billion hedge fund based in New York. Before that, he was vice president at Piper Jaffray for four years, as senior China research analyst covering solar energy and semiconductor materials, based in Shanghai. Mr. Yang started his Wall Street career as an analyst at Dreman Value Management.Mr. Yang holds a Master of Business Administration degree from Cornell University and a bachelor's degree in electronic engineering and computer science from the University of California at Berkeley.CHARACTERISTICS⏹High efficiency and stable performance in photovoltaic conversion.⏹Advanced diffusion technique ensuring the homogeneity of energy conversionefficiency of the cell.⏹Advanced PECVD film forming, providing a dark blue silicon nitride anti-reflection filmof homogenous color and attractive appearance.⏹High quality metal paste for back surface and electrode, ensuring good conductivity,high pulling strength and ease of soldering.⏹High precision patterning using screen printing, ensuring accurate busbar location forease with automatic soldering a laser cutting.MANUFACTURE PROCESSINGReduce the solar cell's reflection of sunlightForm twoseparatelayers on thewaferthrough athermalprocessIsolate theedges ofwafers toachieve acleanseparation ofthe twolayersApply ananti-reflectioncoating to thefront surfaceto enhancesunlightabsorptionPrint silverandaluminumpaste tocell's surfaceto allowsunlight to beabsorbedConnectcontacts inan electronicfiring processFinishedcells aretested andsortedaccording toefficiencylevel andopticalcriteriaTexturing & Cleaning Diffusion IsolationAnti-reflectionPrinting Co-firingTesting &SortingSPECIFICATION⏹Cell Dimensions: 125mm×125mm⏹Area: 148.6cm2⏹Base Material: P-type mono-crystallinesilicon doped with boron⏹Junction: Phosphorous diffused N on P ⏹Front Electrode: Screen-printed, silverpaste⏹Anti-reflecting Coating: Si3N4⏹Back Surface Filed: Screen-printedaluminum paste⏹Rear Electrode: Screen-printed, silverpasteFACILITIESHebei OfficeLocated in Ningjin, HebeiLaunched in 2007Headerquaters Located in Zhabei, ShanghaiMoved in Dec. 2007SOLAR CELL MANUFACTUREYangzhou FactoryLocated in Yangzhou, Jiangsu,Phase I facilities which occupies 16.36 hectares Launched in 20089 lines with 225MW at the end of 2008Hebei FactoryLocated in Ningjin, HebeiLaunched in 2006 17 lines with 425MW at the end of 2008Capacity Expansion in 20082575175500-6001,00030060090012001H06A4Q06A3Q07AYE 08EYE 09E(产能MW )June 2008July 2008August 2008September 2008October 2008Date December 2008DateNingjin, HebeiYangzhou, JiangsuAdditional Capacity 50 MW 50 MW 50 MW 50 MW 50 MWAdditional Capacity>75 MW2008 ProductionTop 5 Cell Producer by 20083893633362072001761701651461321008478-8360290200400Q -C e l l sS h a r pS u n t e c hK y o c e r aF i r s t S o l a rM o t e c hS o l a r W o r l dS a n y oY i n g l iS u n P o w e rS c h o t t C h i n a S u n e r g yG i n t e c hT r i n a S o l a r#102007 Production581.6504497.5473290281.5277272237215210190180200400600Q -C e l l sF i r s t S o l a rS u n t e c h P o w eS h a r pK y o c e r aY i n g l iJ A S o l a rM o t e c hS u n P o w e rS a n y oT r i n a S o l a r E n e r g yS o l a r W o r l dG i n t e c h# 7SALES NETWORKNEWS & EVENTWith a view of global business development we are participating in various marketing activities aggressively-tracing latest PV news and building up our brand as well. We are ready to make JA Solar the largest solar cell manufacturer, and to bring solar power –the green energy to everywhere.April 13, 2010。

Final Inspection Guideline-rev1 - C&

Prepared by: Date:1. Scope适用范围This is applied for QA inspectors for final inspection of product being produced for The Children’s Place.该方法适用于QA验货员在对The Children’s Place正在生产的产品作尾期检验中使用。

2. Objective目的This outlines the procedure of conducting final inspection at field which is to provide a quantitative level of visual and functional appearance, measurement, and packing prior to shipment of finished product to The Children's Place.本手册概述了QA验货员在The Children's Place产品走货前到工厂进行尾期验货，其中包括对产品外观、功能、尺寸以及包装等各个方面量化评级。

3. Reference Document参考资料TCP Vendor Guide《供应商指南》4. Definition定义AQL – Acceptance Quality Level, the maximum allowable percent defective canbe considered satisfactory in a sampling inspection as specified in theinternational standard, ANSI/ASQC Z1.4 Sampling plan for inspection.AQL –可接收质量限。

是指在随机抽样中可接收的疵点最大百分率，抽样方法是按照诸如ANSI/ASQC Z1.4检验中的随机抽样方法的国际标准随机抽样。

Final Draft

Pre-Sessional English ProgrammeWritten Assignment Final DraftAugust 2014Student Number: 140228380Student Name: Lei CaoGroup: PSP130Assignment title: Austerity measures have been proven to work against a recessionAssignment title number: 1Word Count: 1285Have austerity measures been proven to work against a recession？It was about 6 years ago that erupted the Financial Crisis, after when the global economy had fallen into a recession which is commonly believed the severest one since 1930s. As a consequence of a recession, people losing jobs, less welfare, a significant number of companies and financial institutions bankrupted. Many countries chose to cut government expenditures, namely austerity measures, at the beginning of the recession.There were several arguments on whether austerity measures really work for the recession. On one hand, some people argued that austerity measures should be taken to control expenditures during a recession. On the other hand, others believed that austerity is not the solution. This essay tends to agree with the latter opinion. Firstly, arguments of efficiency of austerity measures will be revealed. Then, reasons why this essay disagrees with those arguments will be revealed. Thirdly, arguments of inefficiency of austerity measures in a recession will be demonstrated.First, some view believed that austerity measures were effective for the economy during a recession, by which expenditure of social sectors can be cut as generous welfare benefits may bring about unwillingness of taking a job and voluntary unemployment during a recession. Pettinger(2011) pointed out that generous government would discourage people to work. Austerity measures should be imposed to fit the down-turn of the economy. In other words, If government chooses to impose austerity measures, not only would this encourage people to find a job but also would release the burden of government, for spending less in its budget. It seems true that austerity measures are indirectly encourage people to work. However, the shortage of liquidity in social sectors which is on account of austerity measures may cause a substantial amount of marginalized employers losing their jobs. Life for commonpeople will be desperately harder, especially for those whose living largely depended on government welfare. For instance, Caldas (2012) took Portugal as an example and established that there was a strong recessionary impact since March 2010 when the austerity measures had been adopted. Unemployment rates had unprecedentedly reached 15.6 per cent in March 2012. The rate of youth unemployment aged 15 to 24 had registered 36.2 per cent. Nominal wages had declined 3.9 per cent from September 2010 to March 2011.Nevertheless, some other views argued that austerity measures work against a recession. As a result of unemployment, the crime rate may accordingly rise and social order fell into the risk of turbulence, which may increase the possibility of a continued recession. It was established by United Nation (2013) that many countries had responded to the adverse impacts on people‟s living standard with austerity measures that significantly cut spending in social sectors. For instance, as a consequence of reduced investment in public service, people who were in danger of marginalization become harder to survive from being discriminated, which lead to the probable violation of human rights.Second, there was also a point of view which claimed the efficiency of austerity measures to a recession. They argued that the decreasing of government expenditure releases the stress of taxpayers. From the other direction, stimulus packages which is the opposite policy of austerity measures increase the burden of taxpayers. Taxpayers‟ situation would be better if government spends less, since the majority of government incomes are originated from revenue ( Pettinger, 2011). It is undeniable that the major proportion of fiscal revenue is from taxpayers, but this does not mean that taxpayers really responsible for the government debt. Technically, it is well known that the main source of incomes of government is taxes and the expenditure of government indirectly related to the taxpayers, which seem that a government cannot survive without tax incomes.However, as a matter of fact, if government is lack of money, government bonds can be issued to borrow money from global capital markets. Before the maturity of the bonds, government usually issues new bonds to pay the former one. Actually, it is an inexhaustible money creation system which relies on government‟s constancy and high level of credit rating. Further more, the scale of debts can be automatically contracted by devaluing its own currency to debtor‟s. Because of this gifted financial innovation, those are not the problems of taxpayers in reality (Mankiw, 2009).Third, people who believe the efficiency of the financial market during a recession argue that a recession is one of the phenomena of economic cycle, and what government should do is to impose austerity measures until the economy recover spontaneously. The International Monetary Fund (2009) revealed that no matter what stimulus packages imposed, the economy might still stagnate in recession for a long period. Rather than useless and bottomless increasing government spending for aiding social sector, imposing austerity measures will be beneficial for economic structural reform. To some extent, the financial crisis resulted from unmatched economical structure, and what most unexpected benefit a recession can bring about is the fantastic opportunity of reforming social sectors, by which austerity measures streamline the administrative and social structure.It seemed like that austerity measures have positive impacts on encouraging reforming social sectors.However, Reeves(2013, p 6) conducted an analysis on the impacts of austerity measures and successfully observed that: “In the UK, The government has argued that there is no alternative to austerity. Yet, several countries have averted deep budget cuts. There is no evidence that their economies have suffered as a result.”If governments entangle in a dilemma of which decision should be made to recover our economy, namely, austerity measures or stimulus packages, a variety of problems will occur as a result. Indeed, states imposed stimulus packages have benefited other than budget-cutting states, it is the …stimulus countries‟that had benefited more. As amatter of fact, austerity measures cost substantially more than what have been brought (Breuer, 2011). For instance, the continuously increased Debt-GDP ratio, the rise of the unemployment rate, and the problems above due to without taking completed austerity measures.Many countries chose to impose austerity measures at the very beginning of 2008 financial crisis. Nevertheless, this did not prove austerity measures really work against a recession. Austerity measures are imposed just as emergent measures to prevent the economy from getting worse further but not the solution to deal with a recession. For example, the recovery of economy require enormous amount of money to be injected into the financial system and social sectors (Mankiw, 2009). Without of new investments and recreation, it is impossible for the economy recover from a recession. Similarly, it is impossibl e for a poor family‟s situation getting better only by spending less without finding a job and making money. Nechio(2011) successfully argued that although austerity measures have positive impacts on the economy in the short term, it is the stimulus packages that really work for a recession in the long run.In conclusion, this essay tends to believe that austerity measures have negative impacts during a recession. Firstly, It is inevitable that austerity measures almost have a full spectrum of impacts on e veryone‟s living. However, cutting government expenditure is only one of the crucial emergency procedures to prevent worse effects. To calm the market, stimulus packages will be imposed sooner or later. It is the immense capital injection from the government that could regenerate social sectors, recreate new jobs and recover people‟s living standard. Secondly, imposing austerity measures cost more than economic problems. As a result of poorer society, the gap between rich and poor is widened, the distribution of social resources is more unfair, rate of crime. At last but not least, increasing government spending to save the economy is the right decision for the long term.Reference:1. Breuer, C. Gottschalk, J. and Ivanova, A. (2011) .Germany: Fiscal Adjustment Attempts with and without Reforms. In P. Mauro(ed.) Chipping Away at Public Debt: Sources of Failure and Keys to Success in Fiscal Adjustment, p100–115.2. Caldas, J. (2012). The Consequences of Austerity Policies in Portugal. International Policy Analysis: Friedrich Ebert Stiftung. Available at: http://library.fes.de/pdf-files/id-moe/09311.pdf(Accessed: 31st July 2014)3. IMF. (2013). …Spain: Financial Sector Reform—Fourth Progress Report'. International Monetary Fund Publication. IMF Country Report No. 13/3314. Mankiw, N. (2009). Macroeconomics. Worth publisher , 7, p 481-93.5. Nechio, F. (2011) Long-Run Impact of the Crisis in Europe: Reforms and Austerity Measures. Frbsfeconomic.Letter.Accessedat:///economic-research/publications/economic-letter /2011/march/europe-crisis-reforms-austerity-impact/(Accessed:20th Aug 2014)6. Pettinger,T. (2011). Is Big Government Bad for Economic Growth? Available at: www. economics /blog/category/economics/ (Accessed: 1st Aug 2014 )7. Reeves, A., Basu, S., McKee, M., Marmot, M. and Stuckler, D.(2013). …Austere or not? UK coalition government budgets and health inequalities‟, Journal of the Royal Society of Medicine, 0(0) 1–5.8. United Nations. (2013). Report prepared by the United Nations High Commissioner for Human Rights on austerity measures and economic and social rights.。

Final

In today’s society, schizophrenia has become one of the central concerns in human mental health. To define it, schizophrenia is a chronic, severe, and disabling brain disorder that people have been suffering through out human history which could be recorded, and one percent of Americans are being affected (Schizophrenia January, 2007). There are 4 main factors that can cause schizophrenia, genetic component, brain damage at birth, environmental effects, drug of abuse and alcoholism, which the former two and the latter ones refer to inherited factors and postnatal influences respectively (The causes of schizophrenia 2007; Schizophrenia 2004). To recognize the state of this illness, observing the various symptoms that can be distributed into positive and negative parts is a common method, and it is also helpful for the people around the patients to prepare some early prevention. The current treatments for schizophrenia are quite simple and effective which only include medication and psychosocial treatment (Schizophrenia 8th October, 2005; Treatment options for people with schizophrenia [Treatment] 26 July, 2007). Therefore, family awareness and early-stage prevention are largely needed; also new treatments should be developed to cure the illness.In the first place, there are two main categories of symptoms of schizophrenia that can help people to recognize, which are positive symptoms and negative symptoms. Firstly, positive symptoms include hallucinations, delusions, thought disorders and the feeling of being controlled. Hallucination is a symptom that sufferers feel, hear, smell or see something which does not exist or is not happening at all (Schizophrenia 2004). The most common hallucination is auditory one which also refers to two most frequent types (Dow nd). Stated by Merrel Dow (nd), the first one is that patients are hearing continuous running commentaries of them and the other one is hearing two other voices talking or usually arguing about them. Next symptoms are delusions which normally have two kinds (Dow nd). One of them could be defined as an incorrect belief that a patient holds without doubt despite an opposite proof and no understanding from others (schizophrenia 2004; Schizophrenia January, 2007; Dow nd). Bizarre delusion is the second kind; it is not only a false belief which isimpossible but even ridiculous (Dow nd). To a large extent, it is the same thing as the feeling of being controlled. In this case, patients often feel there are being taken away from their minds and as a result, they are not able to think properly (Schizophrenia 2004; Dow nd). Furthermore, they might feel the thing they are considering is other people’s though ts, and their bodies are being controlled like puppets (Schizophrenia 2004). The last marked positive symptom is thought disorder. It means the patients find it is pretty hard to complete tasks, they cannot concentrate on the things they are doing, such as watching TV, finishing homework and so on (Schizophrenia 2004; Dow nd). Next, the negative symptoms are certainly a lot more severe. They can fit into two categories. The first one is effects of emotional state. In this stage, patients usually lose their interests in life; mood, feelings and energy are getting away as well (Schizophrenia 2004). Thought or cognition problem is the other expression of negative symptoms. Under this situation, patients lose their ability to start tasks such as cleaning and tidying up gradually, and their clothes and room become dirty and messy (Schizophrenia 8th October, 2005; Schizophrenia 2004). In addition, they may feel uncomfortable when with people together, because of being unable to think properly and then talking nonsense (Schizophrenia 2004). These are all the common symptoms of schizophrenia, which we should be aware in daily life, and as Merrell Dow (nd) said, even if there are only positive symptoms, “they are far from positive in the sense of being wanted”.Secondly, both inherited and postnatal factors can cause schizophrenia. First of all, genetic component of sufferers is a very strong causation of schizophrenia (The causes of schizophrenia 2007; Schizophrenia 2004). Moreover, brain damage which comes with birth that due to lack of normal oxygen supply or viral infection is also regarded as the other innate origin of schizophrenia (Schizophrenia 2004). Besides the congenital factors, acquired influences are also the emphasis on causing the illness. In this case, environment plays an important role (The causes of schizophrenia 2007; Schizophrenia 11 December, 2007). Environmental triggers such as family problems and childhood deprivation which can create stress to the children are especiallysignificant (Schizophrenia 2004; Schizophrenia 8 October, 2005). Dr. McFarlane (Schizophrenia 11 December, 2007) stated that families which have high expressed emotions are the most likely circumstance to generate schizophrenia according to his research. He further explained that because of high expressed emotion, negative dynamic such as rejection, criticism and anxious over-involvement occurs between children and parents, and the result is a great deal of stress (Schizophrenia 11 December, 2007). Therefore, it is quite important for parents to avoid these kinds of situations or minimize the effect of these sorts of things. Additionally, abuse of drugs and alcoholism also can be possible causations of schizophrenia (Schizophrenia 2004). They usually come from the street and long-term using may trigger the illness if the user is vulnerable (Schizophrenia 2004).At last, the treatments that schizophrenia can use currently are not various but quite effective. The most widely used medication of schizophrenia is antipsychotic treatment. It has been helpful in stabilizing the serious level of illness and reducing possible psychosis in the future (Schizophrenia 8 October, 2005; Treatment 26 July, 2007). Meanwhile, there are two phases of antipsychotic medication. A higher usage stage is needed to treat an acute phase, and it should be followed by a maintenance stage which could be life-long and not so much dosage (Schizophrenia 8 October, 2005). Besides medication, psychosocial treatment is also important. It helps the patients to recover their emotion, motivation of life and ability in communicating with others (Schizophrenia 8 October, 2005; Treatment 26 July, 2007). Furthermore, individual psychotherapy that has regular meetings only between the patient and the therapist is very necessary. The sessions usually focus on past and present problems of the patient in thinking, feeling and communication (Schizophrenia 8 October, 2005). In addition, rehabilitation which includes skill training for jobs and problem solving might be necessary for some patients (Schizophrenia 8 October, 2005). Moreover, family members can help the patients a lot in recovering from schizophrenia (Schizophrenia 8 October, 2005; Treatment 26 July, 2007).Consequently, as schizophrenia not only does harm to the sufferers but also affects family’s normal life and the wellbeing of society, people should help the patients insofar as possible. By knowing the probable inherited and environmental causes as well as some primary symptoms of schizophrenia, early prevention and restrictions such as avoiding family over-stress, keeping children away from drugs and alcohol are necessary to be done. Additionally, though current treatments of schizophrenia such as the use of antipsychotic and individual psychotherapy meetings are pretty efficacious, variety of effective treatments should be developed to cure the illness. In conclusion, people ought to have the awareness of the possibility and symptoms of schizophrenia in order to do early therapy, and new treatments of schizophrenia are needed (Schizophrenia January, 2007).。

C-GMP QA

Guidance for IndustryQuality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)September 2006Pharmaceutical CGMPsGuidance for Industry Quality Systems Approach to Pharmaceutical CGMP RegulationsAdditional copies are available from:Office of Training and CommunicationDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htm.(Tel) 800-835-4709 or 301-827-1800orCommunications Staff, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish Place, Rockville, MD 20855(Tel) 301-827-3800/cvm/guidance/published.htmlU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)September 2006Pharmaceutical CGMP RegulationsTABLE OF CONTENTSI.INTRODUCTION (1)II.BACKGROUND AND PURPOSE (1)A.Background (1)B.Goal of the Guidance (2)C.Scope of the Guidance (3)anization of this Guidance (4)III.CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS (4)A.Quality (4)B.Quality by Design and Product Development (4)C.Quality Risk Management (5)D.CAPA (Corrective and Preventive Action) (5)E.Change Control (5)F.The Quality Unit (5)G.Six-system Inspection Model (6)IV.THE QUALITY SYSTEMS MODEL (8)A.Management Responsibilities (8)1.Provide Leadership (8)2. Structure the Organization (9)3.Build Your Quality System to Meet Requirements (9)4. Establish Policies, Objectives, and Plans (10)5.Review the System (10)B.Resources (12)1.General Arrangements (12)2.Personnel Development (13)3.Facilities and Equipment (13)4.Control Outsourced Operations (14)C.Manufacturing (15)1.Design, Develop, and Document Product and Processes (15)2.Examine Inputs (16)3.Perform and Monitor Operations (17)4.Address Nonconformities (19)D.Evaluation Activities (21)1. Analyze Data for Trends (21)2.Conduct Internal Audits (21)3.Quality Risk Management (22)4.Corrective Action (22)5.Preventive Actions (23)6.Promote Improvement (23)V.CONCLUSION (24)USEFUL REFERENCE MATERIALS (25)GLOSSARY (27)Guidance for Industry1Quality Systems Approach to Pharmaceutical Current GoodManufacturing Practice RegulationsThis guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.I. INTRODUCTIONThis guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implementing such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replace the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensure full compliance with the regulations.FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.II. BACKGROUND AND PURPOSEA. BackgroundIn August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative. In that announcement, the FDA explained the Agency’s intent to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies. The CGMP initiative was spurred by the fact that since 1978, when the last major revision of the CGMP regulations was published,1 This guidance was developed by the Office of Compliance in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER), the Center for Veterinarythere have been many advances in manufacturing science and in our understanding of quality systems. In addition, many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches. This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's CGMP regulations. The Agency also saw a need to harmonize the CGMPs with other non-U.S. pharmaceutical regulatory systems and with FDA’s own medical device quality systems regulations. This guidance supports these goals. It also supports the objectives of the Critical Path Initiative, which intends to make the development of innovative medical products more efficient so that safe and effective therapies can reach patients sooner.The CGMPs for the 21st Century Initiative steering committee created a Quality System Guidance Development working group (QS working group) to compare the current CGMP regulations, which call for some specific quality management elements, to other existing quality management systems. The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations2) and various quality system models, such as the Drug Manufacturing Inspections Program (i.e., systems-based inspectional program),3 the Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases. The QS working group determined that, although the CGMP regulations do provide great flexibility, they do not incorporate explicitly all of the elements that today constitute most quality management systems.The CGMP regulations and other quality management systems differ somewhat in organization and in certain constituent elements; however, they are very similar and share underlying principles. For example, the CGMP regulations stress quality control. More recently developed quality systems stress quality management, quality assurance, and the use of risk management tools, in addition to quality control. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufacturing world. This guidance is the result of that examination.B. Goal of the GuidanceThis guidance describes a comprehensive quality systems model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations. The guidance demonstrates how and where the elements of this comprehensive model can fit within the requirements of the CGMP regulations. The inherent flexibility of the CGMP regulations should enable manufacturers to implement a quality system in a form that is appropriate for their specific operations.The overarching philosophy articulated in both the CGMP regulations and in robust modern quality systems is:2 See Reference #1.Quality should be built into the product, andtesting alone cannot be relied on to ensure product quality.This guidance is intended to serve as a bridge between the 1978 regulations and our current understanding of quality systems. In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:• A quality system addresses the public and private sectors’ mutual goal of providing a high-quality drug product to patients and prescribers. A well-built quality system should reducethe number of (or prevent) recalls, returned or salvaged products, and defective productsentering the marketplace.•It is important that the CGMP regulations are harmonized to the extent possible with other widely used quality management systems, including ISO 9000, non-U.S. pharmaceutical qualitymanagement requirements, and FDA’s own medical device quality system regulations. This guidance serves as a first step to highlight common elements between the CGMP regulations and Quality Management Systems. With the globalization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-device combination products, the convergence of quality management principles across different regions and among various product types is very desirable.•The FDA has concluded that modern quality systems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approvalregulatory submissions. Manufacturers with a robust quality system and appropriate process knowledge can implement many types of improvements. In addition, an effective quality system, by lowering the risk of manufacturing problems, may result in shorter and fewer FDAinspections.• A quality system can provide the necessary framework for implementing quality by design4 (building in quality from the development phase and throughout a product’s life cycle), continual improvement, and risk management in the drug manufacturing process. A quality system adopted by a manufacturer can be tailored to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.C. Scope of the GuidanceThis guidance applies to manufacturers of drug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM). It may also be useful to manufacturers of components (including active pharmaceutical ingredients)used in the manufacture of these products.This document is not intended to create new requirements for pharmaceutical manufacturing thatgo beyond those established in the current regulations, nor is the guidance intended to be a guidefor the conduct of FDA inspections. Rather, the document explains how implementing comprehensive quality systems can help manufacturers achieve compliance with 21 CFR parts210 and 211. Although the QS working group found that many of the quality system elements correlate with specific CGMP requirements, some do not. The Agency expects compliance with CGMP regulations, and FDA’s inspection program will remain focused on compliance with those regulations.D. Organization of this GuidanceTo provide a reference familiar to industry, the quality systems model described in section IV of this guidance is organized — in its major sections — according to the structure of international quality standards. Major sections of the model include the following:•Management Responsibilities•Resources•Manufacturing Operations•Evaluation ActivitiesUnder each of these sections the key elements found in modern quality systems are discussed. When an element correlates with a CGMP regulatory requirement, that correlation is noted. In some cases, a specific CGMP regulation is discussed in more detail as it relates to a quality system element. At the end of each section, a table is included listing the quality system elements of that section and the specific CGMP regulations with which they correlate. A glossary is included at the end of the document.III. CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMSSeveral key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to the manufacture of pharmaceutical products.A. QualityEvery pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness. For the purposes of this guidance document, the phrase achieving quality means achieving these characteristics for a product.B. Quality by Design and Product DevelopmentQuality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process.5 Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understanding from drug development to the commercial manufacturing processes and for post-development changes and optimization. The CGMP regulations, whenviewed in their entirety, incorporate the concept of quality by design. This guidance describes how these elements fit together.C. Quality Risk ManagementQuality risk management is a valuable component of an effective quality systems framework.6 Quality risk management can, for example, help guide the setting of specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigations and corrective actions.D. CAPA (Corrective and Preventive Action)CAPA is a well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. Quality system models discuss CAPA as three separate concepts, all of which are used in this guidance.•Remedial corrections of an identified problem•Root cause analysis with corrective action to help understand the cause of the deviation and potentially prevent recurrence of a similar problem•Preventive action to avert recurrence of a similar potential problemControlE. ChangeChange control is another well-known CGMP concept that focuses on managing change to prevent unintended consequences. The CGMP regulations provide for change control primarily through the assigned responsibilities of the quality control unit. Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval (21 CFR 314.70, 514.8, and 601.12).Effective change control activities (e.g., quality planning and control of revisions to specifications, process parameters, procedures) are key components of any quality system. In this guidance, change is discussed in terms of creating a regulatory environment that encourages change towards continual improvement. This means a manufacturer is empowered to make changes subject to the regulations based on the variability of materials used in manufacturing and process improvements resulting from knowledge gained during a product’s lifecycle.F. The Quality UnitMany of the modern quality system concepts described here correlate very closely with the CGMP regulations (refer to the charts later in the document). Current industry practice generally divides the responsibilities of the quality control unit (QCU), as defined in the CGMP regulations, between quality control (QC) and quality assurance (QA) functions.•QC usually involves (1) assessing the suitability of incoming components, containers, closures, labeling, in-process materials, and the finished products; (2) evaluating theperformance of the manufacturing process to ensure adherence to proper specificationsand limits; and (3) determining the acceptability of each batch for release.•QA primarily involves (1) review and approval of all procedures related to production and maintenance, (2) review of associated records, and (3) auditing andperforming/evaluating trend analyses.This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in § 210.3(b)(15). The concept of a quality unit is also consistent with modern quality systems in ensuring that the various operations associated with all systems are appropriately planned, approved, conducted, and monitored.The CGMP regulations specifically assign the QU the authority to create, monitor, and implement a quality system. Such activities do not substitute for, or preclude, the daily responsibility of manufacturing personnel to build quality into the product. The QU should not take on the responsibilities of other units of a manufacturer’s organization, such as the responsibilities handled by manufacturing personnel, engineers, and development scientists.8 Manufacturing personnel and the QU are both critical in fulfilling the manufacturer’s responsibility to produce quality products.Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches (§ 211.22):•Ensuring that controls are implemented and completed satisfactorily during manufacturing operations•Ensuring that developed procedures and specifications are appropriate and followed, including those used by a firm under contract to the manufacturer•Approving or rejecting incoming materials, in-process materials, and drug products •Reviewing production records and investigating any unexplained discrepanciesUnder a quality system, it is normally expected that the product and process development units, the manufacturing units, and the QU will remain independent. In very limited circumstances, a single individual can perform both production and quality functions. That person is still accountable for implementing all the controls and reviewing the results of manufacture to ensure that product quality standards have been met. Under such circumstances, it is recommended that another qualified individual, not involved in the production operation, conduct an additional, periodic review of QU activities.G. Six-system Inspection ModelThe FDA's Drug Manufacturing Inspection Compliance Program, which contains instructions to FDA personnel for conducting inspections, is a systems-based approach to inspection and is very 7 Generally, the term quality unit is used in this guidance. However, quality control unit is used when directly quoting parts 210 and 211.8 See Reference #1, comment 91.consistent with the robust quality system model presented in this guidance.9 The diagram below shows the relationship among the six systems: the quality system and the five manufacturing systems. The quality system provides the foundation for the manufacturing systems that are linked and function within it. The quality system model described in this guidance does not consider the five manufacturing systems as discrete entities, but instead integrates them into appropriate sections of the model. Those familiar with the six-system inspection approach will see organizational differences in this guidance; however, the inter-relationship should be readily apparent. One of the important themes of the systems based inspection compliance program is that you have the ability to assess whether each of the systems is in a state of control. The9 See Reference #2; This inspectional approach is currently in use by CDER and by CBER for blood and blood product inspections. CBER and CVM are developing a similar approach for drug product inspections.IV. THE QUALITY SYSTEMS MODELThe goal of this section is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe the long-term benefits of implementing a quality system will outweigh the costs.10This section describes a robust quality systems model that, if properly implemented, can provide the controls to consistently produce a product of acceptable quality. Where applicable, the relationship between elements of this model and CGMP regulations is noted. At the end of each section, a table shows how the specific CGMP regulations correlate to the elements in the quality systems model. As already explained, many of the quality systems elements correlate closely with the CGMP regulations. It is important to emphasize that this guidance is not recommending new regulatory requirements. The guidance is intended to provide recommendations to manufacturers who are implementing, or plan to implement, a quality systems model to help them comply with CGMP regulations. FDA regulatory and inspectional coverage will remain focused on the specific CGMP regulations.The model is described according to four major factors:•Management Responsibilities•Resources•Manufacturing Operations•Evaluation ActivitiesIn each of the sections that follow, the specific elements of a robust modern quality systems model are described. When elements of the quality systems model correlate with specific CGMP regulations, this correlation is noted.A. Management ResponsibilitiesModern robust quality systems models call for management to play a key role in the design, implementation, and management of the quality system. For example, management is responsible for establishing the quality system structure appropriate for the specific organization. Management has ultimate responsibility to provide the leadership needed for the successful functioning of a quality system. This section describes management's role in developing, implementing, and managing a robust quality system. There is some overlap with the CGMP regulations in this section (see the table at the end of the section).1. Provide LeadershipIn a robust, modern quality system, senior management should demonstrate commitment to developing and maintaining their quality system.Quality system plans should be aligned with a manufacturer’s strategic plans to ensure that the system is part of the manufacturer’s mission and quality strategies. For example, quality systems departments normally have equal standing with 10 See Reference #3.other departments within an organization. Quality systems staff are effectively integrated into manufacturing activities and are involved in activities such as nonconformance investigations. Senior managers set implementation priorities and develop action plans. All levels of management can provide support of the quality system by:•Actively participating in system design, implementation, and monitoring, including system review (see IV.A.5.)•Advocating continual improvement of operations of the quality system•Committing necessary resourcesIn a robust quality systems environment, all managers should demonstrate strong and visible support for the quality system and ensure its implementation throughout the organization (e.g., across multiple sites).All managers should encourage internal communication on quality issues at all levels in the organization. Communication should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issues that affect quality, with management included whenever appropriate.2. Structure the OrganizationWhen designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products. Senior managers have the responsibility to ensure that the organization’s structure is documented.All managers have the responsibility to communicate employee roles, responsibilities, and authorities within the system and ensure that interactions are defined and understood.An organization also has the responsibility to give the individual who is appointed to manage the quality system the authority to detect problems and implement solutions. Usually, a senior manager administers the quality system and can, thus, ensure that the organization receives prompt feedback on quality issues.3. Build Your Quality System to Meet RequirementsImplementing a robust quality system can help ensure compliance with CGMP regulations related to drug safety, identity, strength, quality, and purity. Under the quality systems model, the Agency recommends that senior managers ensure that the quality system that is designed and implemented provides clear organizational guidance and facilitates systematic evaluation of issues. For example, according to the model, when documenting the implementation of a quality system, the following should be addressed:•The scope of the quality system, including any outsourcing (see IV.B.4.)•The quality standard that will be followed•The manufacturer’s policies to implement the quality systems criteria and the supporting objectives (see IV.A.4.)•The procedures needed to establish and maintain the quality systemIt is recommended under a modern quality systems approach that a formal process be established to change procedures in a controlled manner. It is also recommended that, when operating under a quality system, manufacturers develop and document control procedures to complete, secure, protect, and archive records, including data, which provide evidence of operational and quality system activities. This approach is consistent with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and appropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropriately reviewed and approved, and available for use (see the CGMPs at § 211.22 (c) and (d)).4. Establish Policies, Objectives, and PlansPolicies, objectives, and plans under a modern quality system provide the means by which senior managers articulate their vision of and commitment to quality to all levels of the organization. Under a quality system, senior management should incorporate a strong commitment to quality into the organizational mission. Senior managers should develop an organizational quality policy that aligns with this mission; commit to meeting requirements and improving the quality system; and propose objectives to fulfill the quality policy. Under a quality system, to make the policy relevant, it must be communicated to, and understood by, personnel and contractors (if applicable) and revised, as needed.Managers operating within a quality system should define the quality objectives identified for implementing the quality policy. Senior management should ensure that the quality objectives are created at the top level of the organization (and other levels as needed) through a formal quality planning process. Objectives are typically aligned with the manufacturer’s strategic plans. A quality system seeks to ensure that managers support the objectives with necessary resources and have measurable goals that are monitored regularly.Under a quality systems approach, managers would use quality planning to identify and allocate resources and define methods to achieve the quality objectives. Quality system plans should be documented and communicated to personnel to ensure awareness of how their operational activities are aligned with strategic and quality goals.5. Review the SystemSystem review is a key component in any robust quality system to ensure its continuing suitability, adequacy, and effectiveness. Under a quality system, senior managers should conduct reviews of the quality system’s performance according to a planned schedule. Such a review typically includes assessments of the process, product, and customer needs (in this section, customer is defined as the recipient of the product and the product is the goods or services provided). Under a quality systems approach, a review should consider at least the following:•The appropriateness of the quality policy and objectives•The results of audits and other assessments。

bib awaiting final decision

bib awaiting final decision
"Bib Awaiting Final Decision" 通常出现在学术或专业出版物的评审过程中，表示论文或稿件已经经过初步审查，并被认为有潜在的学术或专业价值，但还需要进一步的评审和审核才能做出最终决定。

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在这种情况下，作者应该耐心等待评审结果，同时也可以与编辑或出版商保持联系，了解稿件的进展情况。

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final final revision

课堂内容：
1.通知、公告的写作第二次指导。 2.Capital Book 的解题点评。 3.Unit 6 + 5 词法学习。
通知、公告写作要素：
1. 活动____ 2. 活动____ 3. 活动____ 4. 活动___ _名称 5. ____问题 6. 简单的________
通知、公告写作要素：
通知、公告写作试水后点评：
1. 2. 3. 4. 5. 6. 活动名称活动地点活动时间活动主办方名称收费问题简单的规矩指引
• 内容完整（五分） • 语言准确（五分） • 语言流畅（五分）
11月23日上午8点30分至 9：30分，第十六届全国英语比赛在六中长风楼六楼进行。所有参赛同学需要提早 15分钟进入课室，带备铅笔、黑色水笔。相机、手提电话不得带进考场，否则以作弊处理。
It is g______believed that there is a good supply of fresh water. But to our d______, the fact is just the opposite. As we can see, the world population is g______ r_______ day by day. So enough f____ water needed to feed such a big p________. What’s more, with the d_________ of i______, factories and vehicles produce p_____ gases and w_____, which c______ r_______ in the pollution of water. Though fresh, a good amount of it can no l______ be used. Only quite l_____fresh water r_____ is a______ to human beings. So it’s h____ time for us human beings to take quick a______ to protect water r______. Stop pollution and save water. O_____, we cannot survive _____on the earth. With fresh water, the world will be p_______.

GAC002 Final draft

GAC002 Assessment Event 4: Academic EssayAmerican Sign LanguageStudent’s Name: Chen lan(Terry)Student ID#: HFLS27197Teacher: KatrinaDue Date: 8 January 2015Word Count: 488Question: What is meant by sign language? Explain. Use facts, examples, anecdotes or other evidence to clarify this concept.Sign language is the use of gestures to communicate and is an important auxiliary tool of sound language for the hearing impaired people.Different countries have their own sign languages. American Sign Language (ASL) is the most representative sign language in the world. It is similar to English, they both contain impressions. However they have their own outstanding features.It must be say that sign language was not created by American. Actually a great French educator created it. These languages he created used natural sign language which was usually used by the local deaf people. In the eighteenth century, it started being used in America. Thanks to Thomas Hopkins Gallaudet, he was finding out how the deaf community communicates with each other. The Europeans were one step ahead of other. After studying sign language in Paris, he set up the first American school for deaf. Unfortunately, Sign language teaching was replaced by the oral language teaching because of its complicated and nonobjective expression. It was hard for transition at that time.ASL is the best language for the American deaf and is the only way they live and learn. Therefore ASL is regarded as the national language by the American deaf. They have deep emotion for this national language.Learning sign language isnot just good for the deaf. When normal people cannot speak sometimes, they can use gestures to express their feelings.Although gestures can express the meanings correctly, the fact is that what gestures convey is also as abstract as the spoken language. For example, the hearing students use “you” to express themselv es sometimes, because other people always use “you” to expressthemselves.The kids who have learned the gestures of “you” will also make the same mistakes. The mistake is that they point others as themselves. It shows that such easy gestures can be as abstract as the spoken vocabulary.It is worth mentioning that ASL is not just good for the deaf, but also has its benefits for normal people. For preschoolers, it really helps them recognize the word. Young children enjoy movement and action. When sings song and put actions to them, they always remember quickly. For the educated children, it can also help them to study. Sign language enhances language development and improves students' sight word recognition and understanding of the alphabet and phonics. In conclusion, incorporating sign language can take a lot of advantages in class. The reason is that the use of language builds many new paths and storage space in the brain where children can explore information for study.American Sign Language has been a hard time in the past because of its nonobjective expression. However the value of this language was found in time so it was not buried. Now it can be say that it is social, no limitation and morphology. Because of these outstanding features, ASL can be the most representative sign language of the world.ReferencesCarla Zembal-Saul(2008),Benefits of sign language[Online].Available from: /cxz12/blogs/re-inventing_amy/2008/08/benefits-of-sign-lan guage.html [Accessed 28 December 2014]Jami Fisher(2002), Department of Linguistics [Online].Available from:/research/asl[Accessed 28 December 2014]KrammerKlaudia, MA (2013),The benefits of sign language for deaf children with and withoutcochlear [Online].Available from:/index.php/esj/article/viewFile/2485/2358 [Accessed 28 December 2014]National Association of the Deaf (2008),Access to language is a human right[Online].Available from:/issues/american-sign-language [Accessed 28 December 2014]National Institute on Deafness and Other Communication Disorders(2008), American Sign Language [Online].Available from:/health/hearing/pages/asl.aspx[Accessed 28 December 2014]。

Second Paper Final draft

Final DraftYue XuMargaret E. HaunEnglish 105 U1March 4, 2010In April 1992, Chris McCandless, a young man from a wealthy American family hitchhiked to Alaska and walked alone into the wilderness north of Mt. McKinley. He gave his money to charity, left his car and most of his possessions, burned all the cash in his wallet, and invented a new life for himself. Four months later, his body was found by a moose hunter. Four years after McCandless’ death, his experience has been written into the book Into the Wild by a mountaineering journalist--Jon Krakauer.To understand McCandless’ behavior and the appeal of his risky activities, Krakauer traces McCandless’ last two years. After his graduation from Emory University, McCandless abandoned his middle-class family, identity, and possessions in favor of the life of Alexander Supertramp, wandering the American West in search of raw and transcendent experience. After tracing the story of McCandless’ life backwards to his family, Krakauer begins his adventure in the way McCandless did.In order to get firsthand information about McCandless, Krakauer visited nearly all the sites where McCandless had been, trying his best to meet all the people McCandless metalong the way. This method helped Krakauer to appreciate the land as McCandless did. Visiting the sites that McCandless did assisted in Krakauer's research. Krakauer says "I want to visit the bus. I want to see where McCandless died, to better understand why." (355). Jon Krakauer also quoted journals and thoughts written by McCandless which contains entries covering a total of 112 days. These entries range from ecstatic to grim depending on McCandless's changing fortunes. These writings help Krakauer and the reader deduce McCandless’ his mental state.Krakauer suggests that McCandless invented “an utterly new life for himself, one in which he would be free to wallow in unfiltered experience.” He also renamed himself as Alexander Supertramp, “master of his own destiny.” (18) As a mountaineering journalist, Jon Krakauer maintains that nature has no respect for those who are unprepared. Krakauer drew upon his own experience climbing a glacial mountain in Alaska in an attempt to understand McCandless and evidently had the same kind of feelings that McCandless had during his adventure. The most obvious difference is that although Krakauer took huge risks, he was a trained, experienced climber who made appropriate preparations.Krakauer calls McCandless’s death “a terrible accident” that was not, by all appearances, anything other than a series of wrong choices. Eating toxic berries, taking a misstep on the tundra and drinking from the wrong stream—any of these could be one link in a fatal chain. In the northern climates, the smallest mistake can quickly become one’s last. People out for an afternoon hike have been known to die simply because they forgot to pack the right kindof jacket. In Alaska, preparation and forethought are critically important. McCandless assumed he could forage for plants and hunt game. Despite his inexperience as a hunter, McCandless killed some small game such as porcupines and birds. Once he killed a moose; however, he failed to preserve the meat properly, and it spoiled.When Chris McCandless died four months after embarking on his Alaskan adventure, critics accused him of being crazy and stupid, regarded his journey as suicide. As pointed out in Krakauer’s Into the Wild, McCandless was quite an intellect. What led to his demise was the fact that he was so deeply rooted in academia that he lacked the practical knowledge necessary for surviving in the Alaskan wilderness. McCandless was not crazy, nor did he have a death-wish. He simply had needs and desires for self-actualization that were more unique than usual. “That's not uncommon. What is uncommon is the degree to which he needed to test himself.”(NPR) as Krakauer says in the interview.Krakauer amplifies the story of Chris McCandless with his own story and experiences. He searches the evidence of the motivation that drove Chris McCandless to leave civilization behind and journey into the secluded Alaskan wilderness. He identifies McCandless as an intense young man “who thought himself immortal and invincible.”(NPR) Just like many young people in that age do. McCandless was n’t that much different than any of us. What Jon Krakauer finally emphasizes is that Chris wasn't running away from his family and civilization. He was instead running toward his own adventure.Work CitedFilm Captures Young Man's Journey 'Into the Wild'. NPR. 20 Sept. 2007。

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类克Q&A一．疗效1.类克®同益赛普在药代动力学及作用机制等方面的主要区别是什么？2.同益赛普相比类克®治疗RA、AS方面突出的优点是什么？3.哪些RA患者可能对类克®治疗效果显著？4.当患者在接受类克®治疗期间，发现疗效不太显著时，是否可以加量？如何加量？加量之后是否还可以恢复到初始剂量？5.给与类克®治疗后，尤其是在诱导期内，如果疗效不显著，如何调整其他用药从而确保类克®使用后的疗效？6.判断类克®是否有效时的注意事项？7.给与类克®治疗起初症状改善显著，但之后又不明显，是否为继发无效？8.类克®使用的疗程是多久？是否可以停药？9.如果从益赛普转换类克®治疗，如何给药？10.心梗患者是否可以应用类克®？11.JRA患者是否可以使用类克®？12.出现抗核抗体等自身抗体时是否影响类克®使用？二．安全性1.类克®常见的不良反应有哪些？2.使用类克®后结核的发生率是多少？如何进行筛查，预防处理？3.使用类克®后输液反应的发生率是多少？如何进行预防和处理？4.类克®是否会在给药第三次或第四次时输液反应增加？5.若患者出现过输液反应，下次给药时是否可以1支1支间隔给药？6.1瓶250ml的生理盐水可以溶解多少浓度的类克®？7.使用类克®后感染的发生率是多少？如何进行预防和处理？8.发生感染后是否还可以继续使用类克®治疗？9.类克®对患者肝功能有什么影响？10.肝功能不全的患者是否可以使用类克®？11.病毒性肝炎的患者是否可以使用类克®？12.肿瘤患者是否可以使用类克®？13.类克®是否会增加淋巴瘤的发生率？14.糖尿病患者是否可以使用类克®？15.手术患者何时可以使用类克®？16.使用类克®的患者是否可以怀孕？三．其他1.使用类克®后产生抗抗体的几率是多少？是否会影响疗效？2.类克®治疗过程中剂量增加是否与抗抗体的产生有关？3.如何减少抗抗体的产生？4.应用类克®后是否会产生依赖性？疗效2.同益赛普相比类克®治疗RA、AS方面突出的优点是什么？类克®结合TNF-α更强，疗效更显著RA：➢有效抑制影响学进展➢ATTRACT研究中显示类克®抑制关节损害的强度是MTX的12倍➢目前只有抗TNF-α单克隆抗体有临床研究证实MTX无效的患者接受单克隆抗体治疗后能够有效抑制影像学进展，而益赛普对MTX无效的RA患者,无相关X线资料。

➢唯一证明能够停药并继续维持良好疗效的抗TNF-a生物制剂：有Best研究，通过对早期的RA 患者早期联合类克®治疗，发现在使用一年（中位数为12.6月）后，51％的患者可以停用类克®，17％可以停用所有药物，且有着持续良好的疗效（DAS44<2.4）AS：➢对关节外表现如葡萄膜炎、炎症性肠病和银屑病疗效优于益赛普➢有效延缓结构病变的进展：一项强直性脊柱炎患者经类克®治疗4年随访试验显示，类克®可以有效延缓结构病变的进展。

而有研究证实益赛普不能抑制AS患者的影响学进展。

类克®具有个体化的静脉注射方案，给临床治疗带来的益处是：➢个体化剂量：可以根据体重调节剂量，疗效不足时可以根据病情的严重程度调节剂量，而已有研究证实益赛普给药剂量加大后不能增加疗效，反而加重不良反应。

➢使用方便：类克®每2个月给药一次，第一年仅需给药8次，而益赛普每年给药次数104次。

➢安全性高：输注的给药方式能够减少皮下注射导致的局部注射部位的不良反应；同时输注在医院进行，能够得到医护人员更好的监护。

类克®具有诱导缓解剂量，给临床带来的益处是：➢起效时间快：静脉注射，同时配合诱导缓解剂量，在初始注射后的几天内，能迅速达到血浆峰值浓度，产生诱导缓解的作用。

3.哪些RA患者可能对类克®治疗效果显著？➢根据ACR推荐，适用类克®的人群是中重度RA（DAS28>3.2），即肿胀关节数≥5个，同时ESR>28mm/h or CRP>20mg/L➢此外根据临床经验判断，病史短，病情重，快速进展的患者对治疗会更为敏感，参考标准如下：✓CCP(＋) RF(＋)，年青患者，预示预后不好✓MTP跖趾关节受累✓骨和软骨破坏✓激素一撤就反弹4.当患者在接受类克®治疗期间，发现疗效不太显著时，是否可以加量？如何加量？加量之后是否还可以恢复到初始剂量？可以加量。

START试验表明，无论是原发性缺乏疗效，还是继发性缺乏疗效，都可以通过加量后来获得满意的疗效。

加量的方法可以采用每次增加1.5mg/kg，如果SJC或TJC改善小于20％，可以继续加量，但不超过10mg/kg。

在本试验中，有极少数患者加量达四次。

加量之后当治疗取得疗效稳定一段时间后，可以逐步减量到初始剂量。

5.给与类克®治疗后，尤其是在诱导期内，如果疗效不显著，如何调整其他用药从而确保类克®使用后的疗效？➢RA：✓在类克®注射第二次之后若疗效不很明显，可以建议将合用的MTX或其他DMARDs酌情加量✓使用类克®前若一直在使用激素，给与类克®后激素不减量，2－3次类克®治疗症状稳定后激素再逐渐减量✓若患者应用MTX不能耐受，建议和其他DMARDs合用，如CSA环孢素，SASP，LEF ➢AS：✓如果患者处于发病早期，炎症症状重，或者是累及外周关节者，可以加用传统DMARDs，如MTX，SASP6.判断类克®是否有效时的注意事项？➢至少在给与诱导期后才进行判断类克®是否有效➢有时存在炎性指标和临床症状分离现象，有研究显示，接受类克®治疗12周，CRP水平持续降低但ACR20临床改善不显著的患者中，59％的患者在继续类克®治疗的第24周出现了显著的临床指标的改善➢有时患者的心理期待值在治疗初期和以后会有所不同，会导致患者自觉症状改善在治疗后期不如前期显著。

➢有时会有病情的波动而导致治疗效果有所反弹，但只要反弹后的症状或炎性指标仍低于治疗基线期，且从总体趋势来看病情控制平稳，则说明类克®治疗仍然有效7.给与类克®治疗起初症状改善显著，但之后又不明显，是否为继发无效？–目前尚无统一标准来评判，不能就此断定无效–若第四次给药时开始不显著，可能与血药浓度不够有关，需要一段时间才会维持稳定，可以给与加量或缩短给药间隔–考虑调整合并用药8.类克®使用的疗程是多久？是否可以停药？由于RA和AS都是自身免疫性疾病，目前的治疗尚不能治愈此类疾病，因此对于此类疾病的治疗大多提倡终身治疗。

但目前有Best研究，通过对早期的RA患者早期联合类克®治疗，发现在使用一年（中位数为12.6月）后，51％的患者可以停用类克®，5年后19％可以停用所有药物，且有着持续良好的疗效（DAS44<1.6）。

–因此参考BeSt研究：DAS44<2.4，持续6个月后类克®可以逐渐减量并停药，DAS44<1.6，持续6个月可以停用所有抗风湿药物–此外，临床停药参考指标如下：✓ESR<30，✓晨僵<15分钟✓无关节肿✓无关节痛✓无关节压痛持续3－6个月以上可以考虑停药9.如果从益赛普转换类克®治疗，如何给药？–给药时间：不需要洗脱期，在下一次需要给益赛普时直接换成类克®即可–给药方法：仍然保留诱导期，因为益赛普控制不好的患者本身TNF水平很高，需要类克®诱导期冲击治疗–建议用药前做结核筛查10.心梗患者是否可以应用类克®？–心梗病情稳定–结合心功能情况，若为III级及以上不建议使用–11.JRA患者是否可以使用类克®？目前尚无JRA的适应症，但是有国外临床应用的成功报导，同时国外临床经验提示6mg/kg比3mg/kg耐受性更好，抗抗体发生率低。

美国学者观察了122例多关节病变的JIA患者，为期44周，类克®的使用剂量为3～6 mg/kg，根据病情可上下调整，给药时间为第0、2、6周及随后每8周1次。

结果显示，在取得良好疗效的同时，患者的耐受性亦表现良好。

12.出现抗核抗体等自身抗体时是否影响类克®使用？如果患者抗体滴度低（每个医院监测方法不同，正常参考值差别大），也无相应临床症状，建议联合使用MTX或中小剂量激素，若滴度高或出现临床症状，发热，皮疹等（应排除药物过敏），建议停药并加用激素治疗。

安全性1.类克®常见的不良反应有哪些？⑴上呼吸道感染；⑵泌尿系感染；⑶皮肤反应；⑷恶心；⑸咳嗽；⑹腹泻；⑺乏力；⑻背部疼痛；⑼头痛；⑽输液反应。

上述反应一般不影响治疗，经过相应的治疗后可以继续用药。

2.使用类克®后结核的发生率是多少？如何进行筛查，预防处理？结核发生率：RA患者使用类克®后出现结核感染的几率有一定差异，和当地总体人群结核感染率有关。

欧美使用类克®的患者出现TB感染的几率大于正常人群，但是结核的发生可以预防。

通过进行用药前结核的筛查和预防性治疗，结核的发生率可以明显下降。

✓–国内临床IV期ROSTRA 研究中入组了234位患者，仅有1例疑似TB✓–日本5000例类克®患者的跟踪随访中，发生TB 14例，0.3%，和正常人群无差异筛查和预防：使用类克®前，建议所有患者都进行PPD皮试，并注意详细询问过去史和接触史，同时进行X线胸片检查。

根据PPD皮试和X线结果综合判断结果。

目前中国正在制定使用TNF 阻滞剂患者的结核筛查指南，以下建议是根据目前我国的临床操作常规和国外相应的指南作的简要说明，仅供内部参考，临床病例需医生根据患者的风险/效益进行综合评估。

1.PPD<10 mma)如果胸片正常，无肺外结核病史，可以使用TNF 阻滞剂，建议6个月复查胸片一次。

如果用药过程中有发热，盗汗等症状，需及时检查除外结核。

b)如果患者胸片有陈旧结核证据或肺外结核病史，需有医生向患者交代TNF 阻滞剂有激活结核的可能，如果病情需要TNF 阻滞剂治疗，建议异烟肼（INH）或利福平（RPF）预防治疗的同时使用，并建议每1－3个月（因为类克®激活结核多发生在首次用药90天内）复查胸片一次。

c)如果胸片有活动性肺结核，先正规抗结核治疗，暂不用TNF 阻滞剂。