Faddeev-Niemi Conjecture and Effective Action of QCD
《制定关于标准必要专利的欧盟方法》英语原文
EUROPEANCOMMISSIONBrussels, 29.11.2017COM(2017) 712 finalCOMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIALCOMMITTEESetting out the EU approach to Standard Essential PatentsI NTRODUCTIONThe interplay between patents and standards is important for innovation and growth. Standards ensure that interoperable and safe technologies are widely disseminated among companies and consumers. Patents provide R&D with incentives and enable innovative companies to receive an adequate return on investments. Standards1frequently make reference to technologies that are protected by patents. A patent that protects technology essential to a standard is called a standard-essential patent (SEP). SEPs therefore protect technologies that are essential for complying with technical standards and for marketing products based on such standards.Standards support innovation and growth in Europe, in particular providing for interoperability of digital technologies that are the foundation of the Digital Single Market (DSM). For example, computers, smartphones or tablets connect to the internet or other devices via standardised technologies such as long-term evolution (LTE), WiFi, or Bluetooth, all of which are protected by SEPs. Without the widespread use of such standardised technologies, such interconnectivity would not be possible2.In the hyper-connected era, interconnectivity becomes even more crucial. A wide range of new products need to be interconnected, as to provide consumers with additional products and services (e.g. smart house appliances) and to create new business opportunities for European companies.The digitalisation of the economy creates great opportunities for EU industry. The estimated economic potential of IoT applications in devices for humans, homes, offices, factories, worksites, retail environments, cities, vehicles and the outdoors will be up to EUR 9 trillion per year by 2025 in developed countries3. The digitalisation of products and services can add more than EUR 110 billion in revenue to the European economy per year over the next five years4. The ability of connected devices and systems to work together is crucial for maximising this economic potential. Without interoperability, enabled by standards, 40 % of the potential benefits of IoT systems would not be reaped5.Without formal standardisation and SEPs, there would be, for example, no connected vehicles. Telediagnosis or remote operations with distant hospitals or to exchange patient information would not be possible either. Patent holders contribute technology for developing standards within standard developing organisations (SDOs). Once a standard is established and the holders of the SEPs have given a commitment to license them on fair, reasonable and non-discriminatory (FRAND) terms, the technology included in the standard should be available to any potential user of the standard. Smooth licensing practices are therefore essential to guarantee fair, reasonable and non-1Regulation (EU) 1025/2012 on European standardisation defines the meaning of the terms “standard” and “technical specification”. In this document the term “standard” is used with both meanings for the sake of brevity.2 For instance, company X marketing residential alarm systems connected to the internet both via WiFi and LTE to provide consumers with enhanced security in case of power cut, would need a licence for these standardised technologies.3McKinsey, 2015. See also the objective set by President Juncker for 5G and the IoT in the State of the Union speech, 14.9.2016.4PricewaterhouseCoopers, 2015 and Boston Consulting Group, 2015. See also: https://ec.europa.eu/digital-single-market/en/digitising-european-industry#usefullinks5 See McKinsey (2015).discriminatory access to the standardised technologies and to reward patent holders so they continue to invest in R&D and standardisation activities. This in turn plays a prominent role in developing a connected society, where new market players outside the traditional ICT sectors (producers of household appliances, connected cars, etc.) need access to the standardised technology.The evidence however suggests that the licensing and enforcement of SEPs is not seamless and may lead to conflicts. Technology users accuse SEP holders of charging excessive licensing fees based on weak patent portfolios and of using litigation threats. SEP holders claim that technology users 'free ride' on their innovations and consciously infringe intellectual property rights (IPR) without engaging in good faith licensing negotiations6. Problems may be particularly acute when players coming from new industrial sectors who are unfamiliar with the traditional ICT business need access to standardised technologies. Disputes and delays in negotiations between technological users and holders may ultimately delay the widespread use of key standardised technologies. This can hamper the development of interconnected products in Europe, eventually affecting the competitiveness of the EU economy.In its April 2016 Communication on Standardisation Priorities for the Digital Single Market7, the Commission identified three main areas where the SEP licensing environment could be improved: opaque information on SEP exposure; unclear valuation of patented technologies reading on standards and the definition of FRAND; and the risk of uncertainty in enforcement of SEPs. In addition, the role of open source communities in the development of standards also should be assessed.There is therefore a need for a clear, balanced and reasonable policy for Standard Essential Patents in the EU with the aim of contributing to the development of the Internet of Things and harnessing Europe's lead role in in this context.Conflicting interests of stakeholders in certain SDOs may make it difficult for these organisations to provide effective guidance on such complex legal and intellectual property (IP) policy issues. Licensing platform initiatives in this area are still at an early stage and have not yet been adopted by implementers, who may well be hesitant given the uncertainty in the current SEP regulatory environment and who have little incentive to enter into a deal in this context.In addition, the standardisation of 5G and IoT is a global issue. Europe's industry retains a leading position in many sectors in global markets. The Commission notes the important role European standardisation plays in the global context8.The Commission therefore considers that there is an urgent need to set out key principles that foster a balanced, smooth and predictable framework for SEPs. These key principles reflect two main objectives: incentivising the development and inclusion of top technologies in standards, by preserving fair and adequate return for these contributions, and ensuring smooth and wide dissemination of standardised technologies based on fair access conditions. A balanced and successful policy on SEPs licensing should work to the benefit of start-ups in 6The economic stakes are very high: for example, the royalty income for 2G, 3G and 4G standards is approximately EUR 18 billion per year (CRA 2016).7The public consultation organised by the Commission in 2014 clearly shows divergent opinions on the challenges and solutions concerning the SEP environment. See http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=7833.8 Patents declared to the ETSI represent 70% of worldwide SEPs (IPlytics, 2017).Europe and should serve all EU citizens by giving them access to products and services based on the best performing standardised technology.This Communication draws on the responsibility of all actors in the SEP licensing context, and all stakeholders are encouraged to contribute to making this framework work in practice. It is not intended to represent a statement of the law and is without prejudice to the interpretation of EU law by the Court of Justice of the European Union (CJEU). It does not bind the Commission as regards the application of EU rules on competition, and in particular Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU).1.I NCREASING TRANSPARENCY ON SEP S EXPOSUREInformation on the existence, scope and relevance of SEPs is vital for fair licensing negotiations and for allowing potential users of a standard to identify the scale of their exposure to SEPs and necessary licensing partners. However, currently the only information on SEPs accessible to users can be found in declaration databases maintained by SDOs which may lack transparency. This situation makes licensing negotiations and the anticipation of risks related to SEPs particularly difficult to navigate for start-ups and SMEs. The primary purpose of declarations is to reassure an SDO and all third parties that the technology will be accessible to users, typically under a commitment to license under FRAND conditions.SDO databases may record tens of thousands of SEPs for a single standard, and this trend is growing9. The declarations are based on a self-assessment by the patent holder, and are not subject to scrutiny regarding the essentiality of the declared patent, which can evolve in the course of the standard adoption procedure. In addition, stakeholders report that even in concrete licensing negotiations licensors fail to substantiate their claims with more precise information. This is particularly unsatisfactory in the context of IoT where new players with little experience of SEPs licensing are continually entering the market for connectivity. The Commission therefore believes that measures, as outlined below, are needed to improve the information on SEPs.1.1.I MPROVING QUALITY AND ACCESSIBILITY OF INFORMATION RECORDED IN SDODATABASESThe Commission believes that SDOs should provide detailed information in their databases to support the SEP licensing framework. While SDO databases collect large amounts of declaration data10, they often do not provide user-friendly accessibility to interested parties, and lack essential quality features. The Commission therefore takes the view that the quality and accessibility of the databases should be improved11. First, data should be easily accessible through user friendly interfaces, both for patent holders, implementers and third parties. All declared information should be searchable based on the relevant standardisation projects, which may also require the transformation of historic data into current formats. Quality processes should eliminate also duplications and other obvious flaws. Finally, there should be links to patent office databases, including updates of patent status, ownership and its transfer. 9For instance, more than 23 500 patents have been declared essential to the Global System for Mobile Communication standard and the 3G or Universal Mobile Telecommunication System standards developed at the European Telecommunications Standards Institute (ETSI). Such standard apply to all smartphones and devices having a mobile connection. For more figures, see 'Landscaping study on SEPs' IPlytics (2017) and 'Patents and Standards - A modern framework for IPR-based standardization' ECSIP (2014).10 Some SDOs require specific patent disclosures as they recognise their benefits, while others permit blanket declarations. This section of the Communication refers to SDOs with specific patent disclosure.11See for example the long running 'DARE' project to improve the ETSI’s database.Work on improving databases needs to be combined with a stricter scrutiny on compliance with declaration obligations as defined in current SDO policies to avoid incomplete declarations12.1.2.D EVELOPING AN INFORMATION TOOL TO ASSIST LICENSING NEGOTIATIONSThe Commission notes that the current declaration system in SDOs supports the technical standard setting process and is not geared towards future SEP licensing. However, it is clear that there are net benefits in extending the current practice and purpose of declarations and databases to the creation of new transparency tools which, without losing their main purpose, can greatly facilitate licensing negotiation. Proportionality considerations are essential in this context. Whilst excessive burdens for stakeholders should be avoided, it should be born in mind that in concrete licensing negotiations, patent holders necessarily have to invest in substantiating to SEP users why patents from the patent holders' portfolio are essential to the standard or how these patents are being infringed13. The Commission therefore believes that proposed incremental improvements with controlled costs can substantially reduce overall transaction costs during licensing negotiations as well as infringement risks, to benefit both parties in negotiations14.1.2.1.More up-to-date and precise declarationsDeclarations occur early on in the standardisation process, with normally no review later on. However, technical solutions proposed in standards negotiations evolve up until the final standard15 is agreed. While the majority of declarations concern patent applications, the patent claims under the final patent granted after adoption of the standard can differ considerably16, as their content may change during the granting process. Therefore, rightholders should review the relevance of their declarations at the time of adoption of the final standard (and subsequent significant revisions) and when a final granting decision on the patent is taken. Declarations should also include enough information to assess patent exposure. Patent holders should at least make reference to the section of the standard that is relevant to the SEP and to the link with the patent family. Declarations should also clearly identify a contact for the owner/licensor of the declared SEP.Finally, it should be noted that SEPs on key technologies are more frequently litigated17. Associated information is relevant for all interested licensees and can play a role in limiting the possibility of future litigation. SDOs should therefore provide the possibility and incentives for patent holders and technology users to report the case reference and main outcome of final decisions, positive or negative, on declared SEPs (including on essentiality and patent validity). As companies usually only litigate a few valuable patents within a portfolio, and both patent holders and users should have an interest in reporting decisions in their respective favour, the associated burden of this measure would be limited.12 For further details, please see the summary report of the public consultation organised by DG GROW in 2015. http://ec.europa.eu/DocsRoom/documents/14482/attachments/1/translations/en/renditions/native.13 See CRA (2016).14 See section 3 below in relation to effective enforcement.15 For instance, a potential patent or patent application initially declared for a candidate technology may not be retained in the released standard, or the declared patent application may be revised during the granting process.16 For instance, 71% of SEPs declared at major SDOs (73% at the ETSI) are only granted after the standard has been released (IPlytics, 2017).17 See ECSIP (2014).1.2.2.Essentiality checksEvidence points to the risk of broad over-declarations and makes a strong case for more reliability with respect to SEP essentiality18. Stakeholders report that recorded declarations create a de facto presumption of essentiality in negotiations with licensees19. This scenario places a high burden on any willing licensee, especially SMEs and start-ups, to check the essentiality of a large number of SEPs in licensing negotiations.There is therefore a need for a higher degree of scrutiny on essentiality claims. This would require scrutiny being performed by an independent party with technical capabilities and market recognition, at the right point in time. Having said this, introducing such a scrutiny requirement to SEPs must be balanced against the cost20. However, an incremental approach, whereby scrutiny takes place at the request of either rightholders or prospective users, calibrating the depth of scrutiny and limiting checks to one patent within a family and to samples, could ensure the right cost-benefit balance of this measure21.1.2.3.Means of implementationWhile there are clear benefits to such increased transparency, the related burden needs to remain proportionate. Measures could therefore be extended gradually, and apply to new and key standards only, e.g. 5G.As a first step, stakeholders could be incentivised to value increased transparency, e.g. by way of certification that their declared SEP portfolios comply with transparency criteria. This certification could later be used in licensing negotiations and litigation. In addition, a recent study undertaken for the Commission suggests that SDOs may consider introducing (modest) fees for confirming SEP declarations after standard release and patent grants, to incentive SEP holders to revise and maintain only relevant declarations22.When considering essentiality checks, patent offices may well be natural candidates for exploiting synergies and reducing costs23. The Commission will support further analysis of their feasibility to ensure effective and proportionate solutions.Depending on the outcome of this project, an independent European body could be tasked to proceed with SEP essentiality assessment.18 See IPlytics (2017) and CRA (2016) and the summary of DG GROW public consultation on SEPs (2015).19 A number of studies on various key technologies suggests that when rigorously tested, only between 10% and 50% of declared patents are essential (CRA, 2016 and IPlytics, 2017).20 The cost of essentiality checks may be negligible compared to licensing revenues for key technologies (see CRA, 2016).21 For an analysis of cost and benefits, please see IPlytics (2017).22 See CRA (2016).23 See IPlytics (2017).2.G ENERAL PRINCIPLES FOR FRAND LICENSING TERMS FOR SEP SThe Commission considers that the parties are best placed to arrive at a common understanding of what are fair licensing conditions and fair rates, through good faith negotiations. Currently, licensing is hampered by unclear and diverging interpretations of the meaning of FRAND. The debate is particularly heated when it comes to valuation principles. Divergent views and litigation over FRAND licensing risk delaying the uptake of new technologies, standardisation processes and the roll-out of IoT in Europe. The Commission considers therefore that it is both necessary and beneficial to establish a first set of key signposts on the FRAND concept, so as to provide for a more stable licensing environment, guide parties in their negotiations and reduce litigation.The guiding elements set out below are based on the results of a public consultation24, analysis of best practices25, studies26, as well as national case law27. The Commission encourages stakeholders to engage in dialogue with each other and with the Commission, with the view to achieving further clarification and developing best practices. The Commission will monitor progress achieved and take complementary action on FRAND licensing, as needed.2.1.L ICENSING PRINCIPLESAs the CJEU has confirmed, an 'undertaking to grant licences on FRAND terms creates legitimate expectations on the part of third parties that the proprietor of the SEP will in fact grant licences on such terms'28.Both parties must be willing to engage in good faith negotiations, with the view to establishing licensing conditions that are fair, reasonable and non-discriminatory. Parties to a SEP licensing agreement, negotiating in good faith, are in the best position to determine the FRAND terms most appropriate to their specific situation.Efficiency considerations, reasonable licence fee expectations on both sides, the facilitation of the uptake by implementers to promote wide diffusion of the standard should be taken into account. It should be stressed in this respect that there is no one-size-fit-all solution to what FRAND is: what can be considered fair and reasonable differs from sector to sector and over time. For this reason, the Commission encourages stakeholders to pursue sectoral discussions with a view to establishing common licensing practices, based on the principles reflected in this Communication.The Commission considers that the following IP valuation principles should be taken into account:Licensing terms have to bear a clear relationship to the economic value of the patented technology. That value primarily needs to focus on the technology itself and in principle should not include any element resulting from the decision to include the technology in the standard.In cases where the technology is developed mainly for the standard and has little market value outside the standard, alternative evaluation 24 Public consultation on patents and standards: A modern framework for standardisation involving intellectual property rights.25 Licensing Terms of Standard Essential Patents: A Comprehensive Analysis of Cases, JRC 201726Study on Transparency, Predictability and Efficiency of SDO-based Standardization and SEP Licensing, Published on: 12/12/2016, (CRA study).27 See, in particular, Unwired Planet v. Huaweï [2017] EWHC 711 (Pat).28 Case C-170/13 Huawei Technologies, EU:C:2015:477, paragraph 53methods, such as the relative importance of the technology in the standard compared to other contributions in the standard, should be considered.∙Determining a FRAND value should require taking into account the present value added29of the patented technology. That value should be irrespective of the market success of the product which is unrelated to the patented technology.∙FRAND valuation should ensure continued incentives for SEP holders to contribute their best available technology to standards.∙Finally, to avoid royalty stacking, in defining a FRAND value, an individual SEP cannot be considered in isolation. Parties need to take into account a reasonable aggregate rate for the standard, assessing the overall added value of the technology30.The implementation of measures on SEP transparency can already support this objective. It can be addressed further, within the scope of EU competition law, by the creation of industry licensing platforms and patent pools, or based on indications by standardisation participants on the maximum cumulative rate that could be reasonably envisaged or expected.2.2.E FFICIENCY AND NON-DISCRIMINATIONThe non-discrimination element of FRAND indicates that rightholders cannot discriminate between implementers that are 'similarly situated'31.Given that FRAND is not one-size-fits-all, solutions can differ from sector to sector and depending on the business models in question.As mentioned above, FRAND negotiations imply good faith negotiations from both parties. Efficiency considerations can come into play as well. Transaction costs relating to the negotiation of a licence should be kept to the minimum necessary. Furthermore, in sectors where cross-licencing practices are widespread, efficiency gains related to such practices should be taken into account. These points need to be taken into account when assessing on a case by case basis whether a licensing offer is compatible with FRAND.In line with the approach presented above, the Commission considers that the same principles of efficiency support the practice of SEP portfolio licensing for products with global circulation32. As noted in a recent ruling33, a country-by-country licensing approach may not be efficient and may not be in line with a recognised commercial practice in the sector.2.3.P ATENT POOLS AND LICENSING PLATFORMS TO FACILITATE SEP LICENSINGThe creation of patent pools or other licensing platforms, within the scope of EU competition law, should be encouraged. They can address many of the SEP licensing challenges by offering better scrutiny on essentiality, more clarity on aggregate licensing fees and one-stop- shop solutions. For IoT industries, and particularly SMEs, newly exposed to SEP licensing disputes, this will bring more clarity to licensing conditions of SEP holders in a specific sector.29The present value is the value discounted to the time of the conclusion of the licence agreement. Allowing for the discounting over time is important against the backdrop of licence agreement running over several years in sometimes technologically fast moving business environments.30 On royalty stacking see CRA study.31 Unwired Planet v. Huaweï [2017] EWHC 711 (Pat).32However, FRAND licensing requires remuneration to be calculated in a manner that implementers wishing to develop a product for a specific, geographically limited area are not placed at a disadvantage.33 Unwired Planet v. Huaweï [2017] EWHC 711 (Pat).Measures to encourage the setting up of pools for key standardised technologies should be encouraged, e.g. facilitating access to pool management offers and technical assistance by SDO34. The Commission will consider further measures if these efforts are ineffective in IoT sectors.2.4.E XPLOITING AND DEEPENING FRAND EXPERTISEThere is a need to increase accessibility of experience, expertise and know-how around FRAND determination. Valuable insight has been gained and approaches developed from licensing agreements, mediations, arbitrations and court decisions over many years. Significant resources and efforts have been devoted to clarifying, analysing and valuing patents and technology. As there is no common repository for such expertise, work and research may be unnecessarily duplicated at serious cost to the parties involved. More accessible FRAND-related information could increase predictability for businesses such as IoT players, facilitate the licensing process in general and provide support and benchmarks in dispute settlement.The Commission will therefore set up an expert group with the view to gathering industry practice and additional expertise on FRAND licencing. In addition, the Commission will use all appropriate tools available to obtain further information to support its policy making with sufficient evidence.34For instance, the creation of pools may be encouraged by means of measures such as strengthening the relationship between SDOs and pools, providing incentives to participation and making universities and SMEs more aware of the advantages of becoming a licensor in a pool (ECSIP, 2015).3.A PREDICTABLE ENFORCEMENT ENVIRONMENT FOR SEP SDisputes on SEPs are an important factor in the licensing system when negotiations fail. A balanced and predictable enforcement environment has particularly positive effects on parties’ behaviour during negotiations, which in turn can speed up the spread of standardised technologies. IoT stakeholders report however that uncertainties and imbalances in the enforcement system have serious implications for market entry. SEPs show a higher degree of litigation than other patents35, which reinforces the need for a clear dispute framework in this area. While this Communication focuses on specific guidance on Standard Essential Patents, the Guidance on certain aspects of Directive 2004/48/EC of the European Parliament and of the Council on the enforcement of intellectual property rights36 clarifies the IPRED regime more generally.The possibility to enforce is one of the key aspects of intellectual property rights37. The debate in the SEPs area has mainly focused on the availability of injunctive relief. Such relief aims to protect SEP holders against infringers unwilling to conclude a licence on FRAND terms. At the same time, safeguards are needed against the risk that good-faith technology users threatened with an injunction accept licensing terms that are not FRAND, or in the worst case, are unable to market their products (hold-ups).3.1.AVAILABILITY OF INJUNCTIVE RELIEF UNDER THE H UAWEI VS ZTE JURISPRUDENCE In its Huawei judgment38, the CJEU established obligations applying to both sides of a SEP-licensing agreement, when assessing whether the holder of a SEP can seek an injunction against a potential licensee without being in breach of Article 102 TFEU. SEP holders may not seek injunctions against users willing to enter into a licence on FRAND terms, and the CJEU established behavioural criteria to assess when a potential licensee can be considered willing to enter into such a licence.The Commission considers that the elements below – which arise from national case-law in applying the Huawei judgment39, provide useful additional guidance for stakeholders.A number of courts have stressed that a prospective SEP licensee has to receive sufficiently detailed and relevant information to determine the relevance of the SEP portfolio and 35 ECSIP (2014).36COM(2017)70837Directive 2004/48/EC of 29.4.2004 on the enforcement of intellectual property rights, pub. OJ L 195 of 2.6.2004, recital 338 Case C-170/13 Huawei Technologies, EU:C:2015:477.39 The CJEU held that Article 102 TFEU must be interpreted as meaning that the proprietor of a patent essential to a standard established by a standardisation body, which has given an irrevocable undertaking to that body to grant a licence to third parties on fair, reasonable and non-discriminatory (‘FRAND’) terms, does not abuse its dominant position, within the meaning of that article, by bringing an action for infringement seeking an injunction prohibiting the infringement of its patent or seeking the recall of products for the manufacture of which that patent has been used, as long as:(1) prior to bringing that action, the proprietor has, first, alerted the alleged infringer of the infringement complained about by designating that patent and specifying the way in which it has been infringed, and, secondly, after the alleged infringer has expressed its willingness to conclude a licensing agreement on FRAND terms, presented to that infringer a specific, written offer for a licence on such terms, specifying, in particular, the royalty and the way in which it is to be calculated, and(2) where the alleged infringer continues to use the patent in question, the alleged infringer has not diligently responded to that offer, in accordance with recognised commercial practices in the field and in good faith, this being a matter which must be established on the basis of objective factors and which implies, in particular, that there are no delaying tactics.。
人类辅助生殖技术质量管理方案
人类辅助生殖技术质量管理方案英文回答:Quality management is crucial in the field of human assisted reproductive technology (ART) to ensure the safety and effectiveness of the procedures. As a professional in this field, I have developed a comprehensive quality management plan that covers various aspects of ART.Firstly, it is important to establish standardized protocols and guidelines for all ART procedures. This includes protocols for ovarian stimulation, oocyte retrieval, embryo culture, and embryo transfer. These protocols should be based on evidence-based medicine and best practices in the field. For example, in the case of ovarian stimulation, the protocol should specify the dosage and timing of gonadotropin administration, as well as the monitoring of follicular development. By following standardized protocols, we can minimize variations in the procedures and ensure consistent quality of care.Secondly, regular training and education should be provided to all staff involved in ART procedures. This includes embryologists, nurses, and physicians. Training should cover not only the technical aspects of the procedures but also the ethical and legal considerations. For instance, embryologists should be trained on the proper handling and culture of embryos, as well as the documentation and record-keeping requirements. By ensuring that all staff are well-trained and up-to-date with the latest developments in the field, we can enhance thequality and safety of ART procedures.Furthermore, a robust quality control system should be in place to monitor the performance of ART procedures. This includes regular monitoring of success rates, such as pregnancy rates and live birth rates, as well as the incidence of complications. By analyzing these data, we can identify areas for improvement and take corrective actions if necessary. For example, if the pregnancy rates are lower than expected, we can review the protocols and procedures to identify any potential issues and make necessaryadjustments.In addition, patient satisfaction should be an important aspect of quality management in ART. Regular patient feedback should be collected to assess their experience and satisfaction with the services provided. This can be done through surveys or interviews. By listening to the patients' perspectives and addressing their concerns, we can continuously improve the quality of care and enhance patient satisfaction.中文回答:人类辅助生殖技术的质量管理至关重要,以确保这些技术的安全性和有效性。
常用药品注册生产英文
缩写词API Active Pharmaceutical Ingredient原料药ANDA Abbreviated New Drug Application简化新药申请仿制药ASM The Active Substance Manufacturer原料药生产厂家ADE Adverse Drug Event药物不良事件ADR Adverse Drug Reaction药物不良反应CFDA China Food and Drug Administration中国国家食品药品监督管理局COS Certificate of Suitability欧洲药典适用性认证CTD Common Technical Documents通用技术文件COA Certificat of Analysis检验报告CDE Center for Drug Evaluation药品审评中心CMC Chemistry,Manufacture and Control化学,生产及质控CRO Contract Research Orgnization合同研究组织ChP Chinese Pharmacopoeia中国药典CAS Chemical Abstracts Service美国化学文摘社CTA Clinical Trail Application临床试验申请CMO Cheif Medical Officer首席医学官CPP Certificate of a Pharmaceutical Product药品证明文书CAPA Corrective and Preventive Action纠正预防行动DMF Drug Master File药品主文件EDMF European Drug Master File欧洲药物管理档案EMEA European Agency for the Evaluation of Medicinal Product欧洲药物评审局EU European Union欧洲联盟EP European Pharmacopoeia欧洲药典FDA Food and Drug Administration食品药品监督管理局(美国药监局)GMP Good Manufacturing Practices良好生产规范HPLC High Performance Liquid Chromatography高效液相ICH International Conference of Harmonization国际协调会议IND Investigational New Drug Application新药临床试验申请IDL Import Drug License进口药品注册证书INN International Nonproprietaty Name国际非专有名称LA Letter of Authorization委托书LOQ Limit of Quantity定量限LOD Limit of Detection检测限MA Marketing Authorization上市许可NDA New Drug Application新药生产上市申请NIFDC National Institutes for Food and Drug Control中国食品药品检定研究院NMT Not More Than不大于NA Not Analysis未检测OTC Over The Counter非处方药OOS Out of Specification不合格PSUR Periodic Safety Update Reports定期安全性报告QOS The Quality Overall Summary质量整体概述QA Qulitity Assurance质量保证QC Qulitity Control质量控制Rx Prescription Drug处方药RS Reference Standard对照品SOP Standard Operation Procedure标准操作规范TS Test Solutions指示剂UV Ultraviolet紫外分光光度法USP United States Pharmacopoeia美国药典药品注册词汇Drug registration application注册申请Supplementary application补充申请Drug regulatory department药品监管部门Re-registration application再注册On-site inspection现场核查Production site inspection生产现场核查Causal inspection有因核查Authenticity真实性Precision准确性Integrity完整性Entrusted agency代理机构Dosage form剂型Formula处方Preparing process生产工艺Testing methods检验方法Quality specifications质量指标Stability稳定性Drug approval number批准文号Method verification方法验证Manufacturer生产厂家Plant工厂Production line生产线Workshop车间Safety安全性Efficacy有效性Acceptance受理Applicant申请人Biological product生物制品Preliminary review初步审核Variation变更Raw data原始数据Specifications verification标准复核Second review复审GMP certificate生产质量管理规范证书Application dossers申请文件Center for food and drug inspection of CFDA CFDA食品药品审核查验中心产品英语部分streptococcus pneumoniae肺炎链球菌Streptococcus pyogenes酿脓性链球菌Branhamella catarrhalis卡他布兰汉姆菌staphylococcus aureus金黄色葡萄球菌Haemophilus influenzae type BB型流感嗜血杆菌Klebsiella pneumoniae肺炎克雷伯杆菌Manufacturing process生产过程Process control过程控制Lysate裂解物Culture培养培养基Ultrafiltration滤过,超滤Inactivation灭活Autolysis自溶Alkaline碱性的Bacterial strain菌株Revitalize复原,激活Sub-culture传代培养Inoculate嫁接Fermenter发酵器Cultivate培养Stir搅拌Concentrate浓缩Turbidity浑浊度Fungi真菌Elimination消除Identify鉴别Purity纯度Germ细菌,病菌Liter升Microbiological control微生物控制Thimerosal硫柳汞Sodium methyl-paraben对羟基苯甲酸甲酯钠Dose and uniformity of dose剂量及均一性Chlorhexidine diacetate乙酰乙酸氯已定Polysorbate80吐温80(聚山梨酯80)Antigenic activity抗原活性Rocket immunoeletroforesis火箭电泳法Excipient辅料Sterile distilled water无菌注射用水Purified water纯化水Appearance性状Container包装Surfactant表面活性剂Preservative防腐剂Leaflet说明书Active ingredients活性成分Approval documents批准证明文件Research data研究资料Stability稳定性Validation of method方法学验证。
以人为本,以临床为导向——美国FDA新药审评模式分析——美国FDA新药评审中的非临床工作
在F A 作 几年 之 后 就 被 制 药 公 司 D工 高 薪 挖 走 。许 多 大 型 制 药 公 司 的 高 级 管 理人 员 都 有 在F A 工 作经 D的 历 。这 也是C E 的工 资是 美 国联邦 DR 政府 中最 高 的一个 原 因 。但是 ,也 有 很 多评 审 员 在F A 工作 了3 年 D中 0
再 是一个 仅仅 局 限于 美 国国 内的管 理机 构 。每天 都有 大 量 的药 品、食 品 从 不 同 的 国家进 入 美 国 ,F A D 正 面 临着全 球化 的巨大挑 战 。药 品评
价 与研 究 中心 ( e t r o D u C n e f r r g
E a u t o a d e e r h C E v l a i n n R s a c , D R)
评 室 和精 神 类 药 物 审 评室 。这 就 足 新 药 审评
的第 一 个 特 点一 一 以适 应 证 为 中 心 。F A D 这 样 安排 的道 理 非 常 简 单 ,对 个 药物 的 “ 风 险一 益 ”评 价 的结 果 可能 随 适 应 证 的不 同 效 而 发 生 变化 。例 如 , 一个 含 有 一 定 毒性 的药
审中心 公认 的出色评 审专家 。我们希 望两位专
物 ,对 于癌 症 病 人 , 效益 可 能 大 于 风 险 。但 家 的文章 对关心 中 国新 药走 向世界 的有识人 士 是 , 如 果 把 它 开 发 成 治 疗 腹 泻 的 药 物 , 风 有所 启发和帮助 。■
专题t持人
酃 谶 憾± 北京大学药物信息与工程研究q心主任 - 李 受力 博士 美国默克公 司亚太地 区药品审评政策研究
FDA仿制药一致性评价指导原则翻译
F D A仿制药一致性评价指导原则翻译Revised by Liu Jing on January 12, 2021仿制药一致性评价指导原则目录I. 简介II. 背景III. 一致性A. 一致性定义B. 一致性范围内的指南1.在待处理的公民请愿、复议申请和终止申请中提出的一致性问题2.有关FDA仍在考虑中的问题3.更适合通过其他机制回复的问题C. 一致性范围外的指南1. 一致性定义中的特殊情况2. 一致性范围外的主题3. 一致性范围外的实体IV. 提交一致性评价A 如何提交一致性评价B 一致性评价的内容C 特殊类型的一致性评价1. 非活性成分2. Q1/Q2 制剂3. 要求多个审核原则的一致性评价D. •一致性评价审核原则V. FDA和提交一致性评价的请求者之间的沟通该指南代表了FDA对该主题目前的看法。
它并不会赋予任何人任何权利,也不会约束FDA或公众,如果有替代的方法能够满足法律法规的要求,可以使用替代的方法,如果想探讨替代的方法,请联系该指南首页中FDA负责执行该指南的工作人员。
I. 简介该指南描述了仿制药生产商以及相关行业向FDA提交仿制药一致性评价,同时描述了FDA针对这些问题提供交流过程。
该指南作为2012《仿制药申报者付费法案》(简称GDUFA)实施的一部分。
FDA的指南文件不会构成任何法律强制职责,而是代表了FDA对该主题的目前想法,仅作为参考意见,除非引用了特定的法规或法定要求。
该指南中“should”表示的是建议执行的内容,而不是必须执行的。
II. 背景2012年7月9日 GDUFA被总统作为法律签署。
制定GDUFA的目的是希望公众能够越来越快速地获得安全且有效的仿制药,同时降低制药成本。
为了应对一系列的监管挑战,在FDA以及仿制药行业代表的讨论中奠定了GUDFA的基础。
GUDFA体现了在公开过程(包括定期公开会议、会议纪要、对来自公众诉讼的评论)接收到的信息。
商定后的建议被发送到国会,国会举行有关GUDFA(包括来自FDA、仿制药行业和其他利益相关方的证词)的听证会。
amending Annex XVII to Regulation (EC) No 19072006
COMMISSION REGULATION (EU) 2016/1005of 22 June 2016amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of theCouncil concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals(REACH) as regards asbestos fibres (chrysotile)(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(1) thereof,Whereas:(1) Entry 6 of Annex XVII to Regulation (EC) No 1907/2006 prohibits the manufacture, placing on the market anduse of asbestos fibres, and of articles and mixtures containing these fibres added intentionally.(2) Member States could exempt the placing on the market and use of diaphragms containing chrysotile fibres forexisting electrolysis installations. This included the possibility to exempt the placing on the market of chrysotile fibres for use in the manufacture or maintenance of such diaphragms and the use of chrysotile fibres for these purposes.(3) Out of five electrolysis installations in relation to which Member States reported (2) in 2011 that they hadgranted exemptions, only two, in Sweden and Germany, remain in operation.(4) On 18 January 2013, pursuant to the obligation in paragraph 1 of entry 6, the European Commission requestedthe European Chemicals Agency (‘the Agency’) to prepare an Annex XV dossier in accordance with Article 69(1) of REACH with a view to prohibiting the placing on the market and use of diaphragms containing chrysotile. On17 January 2014, the Agency finalised the Annex XV dossier, which proposed to amend the existing restrictionby limiting the duration of the exemptions granted by Member States for the placing on the market and use of diaphragms containing chrysotile and of chrysotile fibres used exclusively in their maintenance to 31 December 2025 and enabling Member States to impose a reporting requirement to allow better monitoring and enforcement.(5) The dossier was subsequently put out to public consultation and submitted for examination by the Committeefor Risk Assessment (hereinafter ‘RAC’) and the Committee for Socio-Economic Analysis (hereinafter ‘SEAC’).(6) On 26 November 2014 RAC adopted an opinion concluding that there is no worker exposure to chrysotile inone plant and that in the other exposure is minimised by risk management measures which are effective in controlling potential risks from the use of chrysotile to a risk level of low concern. The opinion further concluded that there is no release of chrysotile to the environment and therefore the health and environment benefits of immediate closure of the two plants would be negligible. Furthermore, due to process and technologyspecific considerations in one of the plants, no suitable alternative was available.(1)OJ L 396, 30.12.2006, p. 1.(2)Exemptions granted by EU countries and EEA-EFTA States on asbestos contained in articles pursuant to Entry 6 of Annex XVII toRegulation (EC) No 1907/2006 (REACH).http://ec.europa.eu/DocsRoom/documents/13170(7) In order to further the objective of phasing out the use of chrysotile in the EU and to improve the clarity andtransparency of the existing exemption, RAC agreed with the proposed amendment set out in the Annex XV dossier. The opinion also concluded that action on a Union-wide basis is necessary.(8) On 9 March 2015, SEAC adopted an opinion noting that in one plant the existing asbestos containing cellswould be dismantled by 2025 and that in the other, the operator claimed that ongoing production level testing using chrysotile-free diaphragms in its current installation would lead to full substitution at the latest by 2025.SEAC also concluded that immediate closure of this plant would result in costs in terms of lost value added and jobs and took note of the commitment of the operator of the latter plant to cease all imports of chrysotile by the end of 2017. Given the overall objective of phasing out the use of chrysotile in the EU and in order to improve the clarity and transparency of the existing exemption, SEAC advised that the duration of the exemptions granted by Member States for the placing on the market of diaphragms and fibres should be limited to the end of 2017 and concluded that the proposed amendment of the existing restriction, as modified by SEAC, is the most appropriate Union wide measure.(9) Commission Implementing Decision 2013/732/EU (1), establishing the best available techniques (BAT)conclusions under Directive 2010/75/EU of the European Parliament and of the Council (2) on industrial emissions (IED), stipulates that the use of asbestos diaphragms is not considered BAT and accordingly permit conditions for chlor-alkali installations operated in the Union must be updated by 12 December 2017 so that those installations do no longer use asbestos diaphragms from that date. However, unlike for mercury cells which are not considered BAT under any circumstances, Member States may determine that, in specific and exceptional circumstances, asbestos diaphragms may be used in a particular installation for a well-defined longer period and under conditions consistent with the environmental objectives of the IED, provided that the conditions and duration of such use are specified in a legally binding way.(10) Since the adoption of the SEAC opinion, the operator of the plant in which full substitution is envisaged by 2025has entered into a binding agreement with the authorities of the Member State concerned with a view to guaranteeing the gradual substitution of diaphragms containing chrysotile by a non-asbestos alternative material from 2014 on and achieving full substitution at the latest by 30 June 2025. Therefore it is appropriate that the duration of the exemption granted by Member States to permit the use of diaphragms containing chrysotile and of chrysotile fibres used exclusively in their maintenance is limited to 30 June 2025 at the latest.(11) Moreover, although under the binding agreement the operator undertook to stop importing chrysotile fibres anddiaphragms containing chrysotile by the end of 2017, it subsequently confirmed that imports have already ceased as it has acquired sufficient chrysotile fibres to manage the transition to an alternative material. Therefore it is appropriate to terminate the possibility that allows Member States to permit the placing on the market of diaphragms containing chrysotile and of chrysotile fibres exclusively for their maintenance.(12) A report indicating the amount of chrysotile used in diaphragms in the installations benefiting from exemptionsshould be transmitted to the Commission. Union legislation on the protection of workers' health and safety already provides that employers must reduce workers' exposure to chrysotile fibres to a minimum and in any case below an established limit value. Member States may set more stringent limit values for such fibres in air and may require their regular measurement/monitoring. The results of any such measurement/monitoring should be included in the report.(13) The Forum for Exchange of Information on Enforcement was consulted and its recommendations were taken intoaccount.(14) Regulation (EC) No 1907/2006 should therefore be amended accordingly.(15) The measures provided for in this Regulation are in accordance with the opinion of the Committee establishedunder Article 133 of Regulation (EC) No 1907/2006,(1)Commission Implementing Decision 2013/732/EU of 9 December 2013 establishing the best available techniques (BAT) conclusions,under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for the production of chlor-alkali (OJ L 332, 11.12.2013, p. 34).(2)Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integratedpollution prevention and control) (OJ L 334, 17.12.2010, p. 17).HAS ADOPTED THIS REGULATION:Article 1Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.Article 2This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 22 June 2016.For the CommissionThe PresidentJean-Claude JUNCKERANNEXIn Annex XVII, entry 6, paragraph 1 of column 2 is replaced by the following:。
服务性领导英文文献
International Journal of Leadership Studies , Vol. 2 Iss. 1, 2006, pp. 36-51Servant versus Self-Sacrificial Leadership: A Behavioral Comparison of Two Follow-Oriented Leadership TheoriesJeffrey A. MattesonRegent UniversityJustin A. Irving Bethel UniversitySince Greenleaf (1977), research pertaining to servant leadership has carved a unique place in the leadership literature. The last decade has produced focused theory development including instrument development and empirical studies. Similarly, since Burns (1978), this era witnessed increased theoretical and empirical attention on the role of leader self-sacrifice. Recently, Stone, Russell, and Patterson (2004) and Smith, Montagno, and Kuzmenko (2004) examined the similarities and differences of servant and transformational leadership. This paper employs analogous methods to examine servant and self-sacrificial leadership. The authors suggest that although servant and self-sacrificial leadership share many common characteristics, they differ in several behavioral dimensions. R esearch pertaining to leadership has been dominated over the last quarter century by the study of transformational leadership (Bass, 1985; Burns, 1978, 2003). This theory represents an important step toward balancing the needs of both leaders and followers as they work toward fulfilling organizational goals. Meanwhile, this same era has produced several other leadership theories which represent a general movement toward follower-oriented models. Two of these models are servant leadership and self-sacrificial leadership.As the original architect behind the contemporary study of servant leadership, Robert K. Greenleaf (1977) captured the essence of servant leadership for a modern audience. Posing the question “Who is the servant-leader?” in his writing, Greenleaf answered by stating:The servant-leader is servant first. . . . It begins with the natural feeling that one wants to serve, to serve first . Then conscious choice brings one to aspire to lead. That person is sharply different from one who is leader first. (p. 27)Since Greenleaf’s initial insistence that a leader should be a servant first, several theories of servant leadership have gradually taken shape, most over the past 15 years. One of the central features of servant leadership which has been clarified in its recent history is that servantleadership is essentially focused on placing the needs of followers before the personal interests of the leader and intentionally working toward raising additional servants. The development of this © 2006 School of Global Leadership and Entrepreneurship, Regent UniversityISSN 1554-3145Matteson & Irving / SERVANT VERSUS SELF-SACRIFICIAL LEADERSHIP 37 view of leadership has several ramifications for organizations, leaders, and followers; not the least of which are the accompanying characteristics, attributes, practices, and outcomes of this behavior (Farling, Stone, & Winston, 1999; Laub, 1999; Patterson, 2003, 2004; Russell & Stone, 2002; Spears & Lawrence, 2002).Self-sacrificial leadership occurs when a leader forfeits one or more professional or personal advantages for the sake of followers, the organization, or a mission. One key aim of self-sacrificial leadership is to encourage follower reciprocity (Choi & Mai-Dalton, 1998, 1999). However, this modeling behavior has the added benefit of potentially moving followers toward an organizational goal; modifying their behavior; or simply persuading them to attribute legitimacy to the leader, thus allowing the leader to gain influence (Choi & Mai-Dalton, 1998, 1999; De Cremer, 2002; De Cremer, van Djike, & Bos, 2004; De Cremer & van Knippenberg, 2004; Halverson, Holladay, Kazama, & Quinones, 2004; Javidan & Waldman, 2003; van Knippenberg & van Knippenberg, 2005; Yorges, Weiss, & Strickland, 1999).In general, leadership theories such as these provide a description of a set of behaviors exhibited by leaders a majority of the time. For example, transformational leaders may still engage in transactional leadership activities in their daily routines. Given this reality, there is often a theoretical overlap of propositions associated with certain leadership models. Additionally, the average experience of organizational followers as they interact with a particular leadership type may vary due to their unique perspective on organizational life. The authors suggest that there is likely a theoretical overlap between servant and self-sacrificial leadership but that a close examination of these theories will reveal several distinct qualities. To date, no theoretical or empirical study has compared these two theories. Therefore, a study is needed that will crystallize our understanding of convergent and divergent aspects of servant and self-sacrificial leadership. Ultimately, this may afford future researchers the opportunity to share a common language of servant and self-sacrificial leadership and lead to useful empirical testing.The purpose of this paper is to describe the chief components of servant and self- sacrificial leadership and to examine the commonalities and distinctions of the two conceptualizations. This study begins by suggesting an integrated model of servant leadership. Subsequent to the delineation of the associated frameworks, the characteristics and attributes of each theory will be laid side by side in an effort to compare the concepts. It is proposed that these two follower-oriented theories share some common characteristics and attributes but differ in significant areas. As a result, a scaffold will be proposed to provide the structure for highlighting the theoretical distinctives of servant and self-sacrificial leadership.Servant LeadershipGreenleaf’s (1977) seminal work on servant leadership—the work attributed with bringing the concept of servant leadership to public discourse in the mid 1970s—has led to a growing body of literature surrounding the construct since the early 1990s. The literature surrounding servant leadership can generally be categorized into two main areas: theoretical and empirical. A majority of the works are theoretical in nature: Blanchard (1998); Buchen (1998); Cerff (2004); Farling et al. (1999); Graham (1991); Hale (2004); Irving and McIntosh (2006), Jennings and Stahl-Wert (2003); Laub (2004); Ndoria (2004); Page (2004); Parolini (2004); Patterson (2003); Patterson and Stone (2004); Quay (1997); Rude (2003); Russell (2001, 2003); Russell and Stone (2002); Sendjaya and Sarros (2002); Smith et al. (2004); Spears (1995, 1998); Spears and Lawrence (2002); Stone, Russell, and Patterson (2003, 2004); Wolford-UlrichINTERNATIONAL JOURNAL OF LEADERSHIP STUDIES 38 (2004); Winston (2003); Winston and Hartsfield (2004); and Wong and Page (2003). An increasing number of empirical studies such as Dennis (2004), Dennis and Winston (2003), Drury (2004), Hebert (2003, 2004), Helland (2004), Irving (2004, 2005a, 2005b), Irving and Longbotham (2006), Laub (1999, 2003), Ledbetter (2003), Sendjaya (2003), and Winston (2004) have emerged as well.As the construct of servant leadership has developed over the last 15 years, it has been operationalized in several different forms. For instance, discussion has focused on the inspirational and moral dimensions of servant leadership (Graham, 1991); the dimensions of self-identity, capacity for reciprocity, relationship building, and a preoccupation with the future (Buchen, 1998); vision, influence, credibility, trust, and service (Farling et al., 1999); along with Russell’s (2001) discussion which focused on vision, credibility, trust, service, modeling, pioneering, appreciation of others, and empowerment. Of the theoretical discussions of servant leadership that have become dominant in the field, Spears (1998), Laub (1999), and Patterson (2003) have been frequently cited. The model of servant leadership that is advanced in this paper is constructed largely as a composite of these three theoretical approaches and is aimed at providing framework for further research in servant leadership studies.Because the model of servant leadership advanced in this paper fuses the Spears (1998), Laub (1999), and Patterson (2003) conceptualizations of servant leadership; it is important to begin our examination of servant leadership by briefly highlighting each at this time. Spears’ (1998) 10 characteristics of servant leadership have been identified as an outgrowth of Greenleaf’s (1977) discussion of servant leadership. Spears’ (1998) 10 characteristics of servant leadership are (a) listening, (b) empathy, (c) healing, (d) awareness, (e) persuasion, (f) conceptualization, (g) foresight, (h) stewardship, (i) commitment, and (j) community building. Spears (1998) argued that servant leadership is tied to the character exhibited by leaders in their essential traits. Spears’ (1998) focus on the character of the leader will be an important consideration as we consider an integrated model of servant leadership. Essential to the formation of servant leaders, Spears’ (1998) 10 characteristics provide a practical starting point for leaders interested in developing as servant leaders.Laub (1999) provided the second core conceptualization of servant leadership that will be utilized in this paper. Laub (1999) defined the essence of servant leadership in this manner: “Servant leadership is an understanding and practice of leadership that places the good of those led over the self-interest of the leader” (p. 81). But, in what manner do servant leaders place “the good of those led over” themselves? For Laub (1999), this is answered by the results of his Delphi study. In the Delphi process, 60 characteristics of servant leaders were identified and eventually clustered into six key areas: (a) valuing people, (b) developing people, (c) building community, (d) displaying authenticity, (e) providing leadership, and (f) sharing leadership. For Laub (1999), these are the essential behaviors that characterize what servant leaders do and are the answer to how servant leaders place the good of those led over their own self-interest.The final base conceptualization of servant leadership is offered by Patterson (2003). As a theory-building dissertation, Patterson (2003) presented servant leadership theory as an extension of transformational leadership theory. This extension was based primarily on Patterson’s (2003) observation that transformational theory was not addressing the phenomena of love, humility, altruism, and casting vision for followers. Because of this, Patterson’s (2003) model of servant leadership includes the following dimensions as the essential characteristics of servant leadership: (a) agapáo love, (b) humility, (c) altruism, (d) vision, (e) trust, (f) empowerment, and (g) service. While Spears’ (1998) model of servant leadership focusesMatteson & Irving / SERVANT VERSUS SELF-SACRIFICIAL LEADERSHIP 39 primarily on the character exhibited by servant leaders and Laub’s (1999) model focuses primarily on the behaviors of servant leaders, Patterson’s (2003) model provides a bridge between the dimensions of character and behavior.Though each of these models provides significant insight into servant leadership, the divergent emphases in each of these models point to the need to consider an integrative model. Toward this end, we propose the following three-fold framework for conceptualizing an integrative model that is inclusive of the wide range of theoretical factors contained in the Spears (1998), Laub (1999), and Patterson (2003) models: (a) being—the servant leader’s ontological character traits; (b) thinking—the servant leader’s attitudinal mindset; and (c) doing—the servant leader’s behavioral actions. Table 1 provides an overview of these three dimensions of servant leadership and the associated factors in the integrative model. This proposed three-fold framework provides a logical approach to assimilating the range of factors in the Spears (1998), Laub (1999), and Patterson (2003) models as well both a linear and circular approach to conceptualizing servant leadership.In the linear approach, we argue that one’s ontological character provides the basis for the attitudinal mindset with which a leader approaches leadership scenarios out of their cognitive-affective framework. Furthermore, we argue that one’s attitudinal mindset provides the basis for servant leadership behaviors (see Figure 1). Thus, this three-fold model may be conceptualized as a linear progression from leader being, to leader thinking, to leader doing; or, to put it in other terms, it is a progression from the ontological, to the attitudinal, to the behavioral.Understood as a circular approach, leader ontology, attitude, and behavior may be seen as regularly reinforcing one another in a circular or spiraling process in which a servant leader’s being (ontological) reinforces servant-oriented thinking (attitudinal) which reinforces servant leadership doing (behavioral) which reinforces servant leader being (ontological); and, the circular reinforcement continues (see Figure 2). Though the notion of circular or spiraling models in servant leadership studies is not new (i.e., Farling et al., 1999), understanding this circular process in light of servant leader ontology, attitude, and behavior is an important addition to the literature.Self-Sacrificial LeadershipThe contemporary origins of the study of self-sacrificial leadership are found in the writings of Burns (1978) and Bass (1985). These transformational leadership theorists suggested that leader self-sacrifice is a tool which great leaders use to motivate followers. Following their lead, current charismatic leadership theorists have perceived self-sacrifice in leadership to be a tactic which a leader could employ to influence follower attributions of charisma (Conger & Kanungo, 1987; House & Shamir, 1993; Shamir, House, & Arthur, 1993). Out of this movement, Choi and Mai-Dalton (1998) proposed a model of follower responses to self-sacrificial leadership. From these theoretical underpinnings, empirical studies have been undertaken to test the validity of this model along with a variety of additional variables which may be associated with self-sacrificial leadership.INTERNATIONAL JOURNAL OF LEADERSHIP STUDIES 40Table 1The Three Dimensions of Servant LeadershipDimensions Servant Leadership Factors LoveHumility Authenticity Self-AwarenessOntological Dimensions of Servant Leadership Self-Differentiation LoveOther-CenterednessOriented toward altruismValuing peopleCommitment to the growth of peopleVisionary Orientation toward trust Orientation toward listeningOrientation toward empathyLeadership mindsetOrientation toward persuasionCapacity for conceptualizationAttitudinal Dimensions of Servant Leadership Foresight LoveListeningEmpathyHealingStewardship Developing people Building communityProviding leadershipSharing leadershipEmpowering followersBehavioral Dimensions of Servant Leadership Serving followersNote. As the foundation of servant leadership (Patterson, 2003), love may be categorized in each of the dimensions of servant leadership.Figure 1. The three dimensions of servant leadership, a linear model.Matteson & Irving / SERVANT VERSUS SELF-SACRIFICIAL LEADERSHIP 41Figure 2. The three dimensions of servant leadership, a circular model.The empirical studies associated with self-sacrificial leadership have focused primarily on the outcomes of the sacrificial behavior on the perceptions of followers. Several of these studies found that self-sacrificing leaders were attributed charisma by followers and were perceived to be more influential, legitimate, and effective (Choi & Mai-Dalton, 1999; De Cremer, 2002; De Cremer et al., 2004; van Knippenberg & van Knippenberg, 2005; Yorges et al., 1999). Follower attributions of charisma were particularly pronounced during a period of organizational crisis or when the organization faced a social dilemma which required cooperation (De Cremer, 2002; Halverson et al., 2004).Self-sacrificial leadership has produced additional responses from followers beyond cooperative effort. Followers of self-sacrificial leaders intended to reciprocate the self-sacrificing behaviors (Choi & Mai-Dalton, 1999), were more committed to their organization (De Cremer et al., 2004), and performed at a higher level (van Knippenberg & van Knippenberg, 2005). The main effects of self-sacrificial leadership have been found to be moderated by leader self-confidence, the leader’s group-orientedness, distributive justice, and when leaders were not pushing their opinions on subordinates (De Cremer, 2006; De Cremer et al., 2004; De Cremer & van Knippenberg, 2004; van Knippenberg & van Knippenberg, 2005). The results of these initial empirical tests hint at a phenomenon, which encompasses a much larger portion of leadership theory than initially proposed. In fact, Choi and Mai-Dalton (1999) suggested that self-sacrificial leadership plays a role in all three organizational processes of production, distribution, and consumption.The proposition of a broad influence of leader self-sacrifice led Choi and Mai-Dalton (1999) to define self-sacrificial leadership as “the total/partial abandonment, and/or permanent/temporary postponement of personal interests, privileges, and welfare in the (a) division of labor, (b) distribution of rewards, and/or (c) exercise of power” (p. 399). The authors explained that self-sacrifice in the division of labor “involves volunteering for more risky and/orINTERNATIONAL JOURNAL OF LEADERSHIP STUDIES 42arduous actions, tasks, turns, or segments of work” (p. 399). They proffer that self-sacrifice in the distribution of rewards “involves giving up or postponing one’s fair and legitimate share of organizational rewards” (p. 399). Self-sacrifice in the exercise of power is described in their research as “voluntarily giving up or refraining from exercising or using the position power, privileges, and/or personal resources one already has in his/her hand” (p. 399). Choi and Mai-Dalton (1999) drew a distinction between self-sacrifice in the distribution of rewards and in the exercise of power by noting that the former involves giving up claiming privileges and the latter involves consuming the privileges.The economic aspects of leader self-sacrifice, while supported both theoretically andempirically, should not be considered the final boundaries of the self-sacrificial leadership construct. Other theorists have noted that leader self-sacrifice includes the loss of status, credibility, and promotion (Conger & Kanungo, 1987; Javidan & Waldman, 2003). This is a small glimpse at the motivational aspects that lay the foundation of self-sacrificial behavior, which may have origins beyond the simple desire to influence followers. After all, if a leader loses his or her status or credibility or is demoted rather than promoted, it would be difficult to impossible to influence followers. Alternatively, leaders may sacrifice to demonstrate courage and conviction in the mission while serving as a role model (Shamir et al., 1993); maintainpersonal beliefs and values (Yorges et al., 1999); and exhibit commitment to the cause (Avolio & Locke, 2002) or, simply, for the good of the company (Halverson et al., 2004). Therefore, it can be stated that the motivational foundation for self-sacrificial leadership may be directly related to the outcome of the behavior.To date, the published theoretical models of self-sacrificial leadership do not address all three dimensions of leader ontology, attitude, and behavior. Instead, current models present the impact of sacrificing behavior on followers along with various moderating variables (Choi & Mai-Dalton, 1999; De Cremer, 2006; Yorges et al., 1999). While a gap in the literature regarding self-sacrificial leader ontology and attitude exists, enough research exists to present behaviors associated with self-sacrificial leaders. Table 2 offers a preliminary look at these self-sacrificial leadership behaviors.Table 2The Behavioral Dimensions of Self-Sacrificial LeadershipDimension Self-Sacrificial Leadership Factors AltruismTakes initiativeEmpathyRole modelingProvides justiceDeveloping peopleBuilding communityProviding leadershipLinks followers to shared visionEmpowering followersServing followersBehavioral Dimensions of Self-Sacrificial Leadership Yields status, privileges, powerMatteson & Irving / SERVANT VERSUS SELF-SACRIFICIAL LEADERSHIP 43Theoretical ComparisonWhile we propose the three-fold circular model of ontology, attitude, and behavior as an integrative answer to the divergent approaches to conceptualizing servant leadership, for the purpose of our comparison with self-sacrificial leadership, we will limit our analysis to the behavioral level. As identified in the literature review surrounding self-sacrificial leadership, the rationale for this is largely due to the relatively focused literature surrounding self-sacrificial leadership on the consequence of the behavior rather than its motivational origins. Certain attitudinal aspects of self-sacrificial leadership can be inferred from the research, but the authors do not support drawing conclusions from these secondary assumptions. While we recommend future explorations into the ontological and attitudinal dimensions of self-sacrificial leadership, the current agenda solely offers self-sacrificial research focused on the behavioral dimension.This section of the paper highlights the similarities and differences of servant and self-sacrificial leadership. In keeping with two previous attempts to compare servant leadership with another leadership theory, the authors have created a matrix to compare the two theories. Stone et al. (2004) and Smith et al. (2004) previously compared servant and transformational leadership, and their graphic representations informed this current effort. In addition to Spears’ (1998) and Laub’s (1999) lists of characteristics which were included in these prior analyses, this paper extends the servant leadership portion by including Patterson’s (2003) attributes in the comparison with self-sacrificial leadership. Recall that in this study, these three theories are presented as an integrated model of servant leadership.In Table 3, the integrated servant leadership behavioral characteristics of Spears (1998), Laub (1999), and Patterson (2003) are listed next to the self-sacrificial leadership factors. The three dimensions of leader ontology, attitude, and behavioral characteristics are listed for servant leadership in an effort to comprehensively present the integrated model. Self-sacrificial leadership attitudinal factors are listed in gray to signify their role as inferred characteristics which will not be used for drawing conclusions. The behavioral factors associated with self-sacrificial leaders as they compare to servant leadership are the primary focus of this study.It is immediately evident that servant and self-sacrificial leadership share several characteristics. The characteristics of empathy, developing people, building community, providing leadership, empowering followers, and serving followers represent overlapping categories. Empathy appears in the self-sacrificial leadership literature through its connection with altruism (De Cremer, 2002). The assumption of an empathy-altruism link, and its support in 25 empirical studies (Batson, Ahmad, Lishner, & Tsang, 2002), sustains this correlation between servant and self-sacrificial leadership. The modeling behaviors found in the self-sacrificial leadership literature shore up the additional characteristics found in both leadership theories. By sacrificing their power, self-sacrificial leaders empower followers. However, this empowerment is likely a product of sacrificing behavior. The shared commitment to service may be explained when self-sacrifice is understood as an extreme act of service. This comparison would evidently indicate that servant and self-sacrificial leaders may view followers in a similar fashion but may choose to interact with them in a slightly different manner.In general terms, it may be stated that both servant and self-sacrificial leaders hold followers in very high esteem but deviate in several core behaviors. First, there is little concrete theoretical or empirical research pertaining to leader self-sacrifice which supports the thought that self-sacrificial leaders share power. Second, it could be argued that the role modeling and altruistic behaviors of self-sacrificial leaders are loving acts and, thus, would compare favorablyINTERNATIONAL JOURNAL OF LEADERSHIP STUDIES 44with servant leadership. However, there are other motivations associated with role modeling and altruistic activities which may have very little to do with love (Avolio & Locke, 2002).Table 3The Three Dimensional Comparisons of Servant and Self-Sacrificial LeadershipDimensions Servant Leadership Factors Self-Sacrificial Leadership Factors LoveHumility Authenticity Self-AwarenessOntological Dimensions Self-Differentiation LoveOther-Centeredness Other-CenterednessOriented toward altruism Orientation toward altruismValuing people Valuing peopleCommitment to the growth of people Commitment to the growth ofpeopleVisionary Visionary Orientation toward trustOrientation toward listeningOrientation toward empathy Orientation toward empathyLeadership mindsetOrientation toward persuasion Self-ConfidentCapacity for conceptualization NonautocraticAttitudinalDimensions Foresight Foresight Love AltruismListening Takes initiativeEmpathy EmpathyHealing Role modelingStewardship Provides justiceDeveloping people Developing people Building community Building communityProviding leadership Providing leadershipSharing leadership Links followers to shared visionEmpowering followers Empowering followersServing followers Serving followersBehavioralDimensions Yields status, privileges, powerListening, healing, and stewardship are currently missing from the self-sacrificialleadership literature. The case can be made that listening is a necessary feature of empathy and that healing is closely aligned with providing justice. Yet, these are unsupported assumptions.Matteson & Irving / SERVANT VERSUS SELF-SACRIFICIAL LEADERSHIP 45 Stewardship is a different matter. In a sense, some self-sacrificial leaders are poor stewards of resources; since by definition, this type of leader may intentionally dispose of resources in orderto achieve an overall goal. Since self-sacrificial leadership theory development is still in relative infancy, the authors feel much more confident in the shared characteristic list and remaincautious in drawing firm conclusions on all of the dissimilar factors. That being said, viewingthese follower-oriented theories through the three dimensions of leader ontology, attitude, and behavior can further delineate both phenomena.Although these two leadership theories share several characteristics, the provisional conclusions stated lead to the understanding that servant and self-sacrificial leadership aresimilar but distinct theories. Since the examination of the behavioral characteristics of these two theories is not capable of revealing a comprehensive understanding of this difference, the authors propose a broader look at servant and self-sacrificial leadership. This effort may bring furtherclarity to this evaluation. An opportunity for an expanded investigation may originate in the previously mentioned work of Stone et al. (2004) and Smith et al. (2004) who offered details regarding the focus, motivation, context, and outcomes of servant and transformational leadership. These four overarching categories can be employed to scrutinize servant and self-sacrificial leadership with the goal of founding an additional baseline for future scholarly discussion. The authors present this brief theoretical comparison in an attempt to launch such a conversation. Table 4 places servant and self-sacrificial leadership in the four categoriesdiscussed in the previous leadership theory comparison. The determination of the focus, motivation, context, and outcome of self-sacrificial leadership is drawn from published research pertaining to this phenomenon. The authors have consulted existing research and selectedgeneral terms to describe each category as succinctly as possible. In other words, an attempt was made to get at the heart or direction of the research to date. For example, since earlier researchhas noted that self-sacrificial leaders may demonstrate courage and conviction in the missionwhile serving as a role model (Shamir et al., 1993), maintain personal beliefs and values (Yorgeset al., 1999), or exhibit commitment to the cause (Avolio & Locke, 2002); the authors haveplaced these activities under the umbrella of ethical self-transcendence in the broad category of focus. Additionally, since self-sacrificial leaders may be motivated by the greater good of the organization (Halverson et al., 2004), the ethical focus underpinning this motivation led theauthors to conclude that self-sacrificial leaders are provoked to serve the greater good.Table 4The Focus, Motivation, Context, and Outcome of Servant and Self-Sacrificial Leadership Focus Motivation ContextOutcomeSelf-sacrificial leadership Ethical self-transcendenceServing the greater good:doing what is morally andethically right, no matterthe sacrificeOrganizational orenvironmentalcrisisDynamicspiritualgenerativecultureServant leadership Followers Serving the good of thefollower: doing what isbest for the followersStableenvironmentSpiritualgenerativeculture。
硝苯地平缓控释制剂制备技术研究进展
・药剂・硝苯地平缓控释制剂制备技术研究进展3何泓良,王卫国33,李 磊,郭家瑞(河南工业大学生物工程学院,郑州450001)摘要:目的 总结近年来国内外硝苯地平缓控释制剂制备技术的研究进展,为硝苯地平缓控释制剂的开发研制提供参考。
方法 查阅了目前主要的硝苯地平缓控释制剂制备技术如缓控释片技术(骨架型技术、渗透泵技术、脉冲技术和薄膜包衣技术)、缓控释胶囊技术、微囊技术、微球技术、脂质体技术和纳米技术,以及一些新技术的文献和资料。
结果和结论 为了更好的满足高血压患者的用药需求,研制可以实现平稳给药和择时给药的硝苯地平缓控释制剂已经成为必然的趋势。
关键词:硝苯地平;缓控释制剂;制备技术中图分类号:TQ46014 文献标识码:A 文章编号:100623765(2009)20820019204作者简介:何泓良,男(19872)。
在读硕士研究生,研究方向为药剂学33通讯作者:王卫国,教授,Email :wwgwang @yahoo 1com 1cn 3基金项目:河南工业大学引进人才专项(2007BS023)Research progress of techniques for preparation of nifedipine sustained and controlled release preparationHE H ong 2liang ,WANG Wei 2guo ,LI Lei ,G UO Jia 2rui (Bioengineering Department ,Henan University of Technolo 2gy ,Zhengzhou 450001,China )ABSTRACT:OBJECTIVE This paper summed up preparation technologies progress of nifedipine sustained and controlled release preparation at home and abroad in recent years ,which can provide reference for studying nifedipine sustained and controlled release preparations 1METH ODS Referencing to a great deal of literature on preparation technologies of nifedipine sustained and controlled release preparation such as technologies of sustained and controlled tablets (technologies for matrix ,osmotic pump ,impulse and film 2coating ),sustained and controlled capsules,microcapsules ,microspheres ,liposomes and nano 1RESU LTS &CONC L USIONS In order to satisfy medication needs of hypertensive patients well ,studying nifedipine sustained and controlled release preparations which can achieve smooth delivery and delivery timing has become an inevitable trend 1KEY WORDS :Nifedipine ;Sustained and controlled release preparations ;Preparation technology 硝苯地平(Nifedipine ,NP )是一种二氢吡啶类钙离子通道拮抗剂,是目前公认安全有效的一线降压药物之一,它还具有治疗冠心病与心绞痛的作用。
国外抗生素监管和研发政策对我国的借鉴
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美国FDA指导原则CVMGFI200SEG用于指定用于小动物的新药物英文原版
美国FDA指导原则CVMGFI200SEG用于指定用于小动物的新药物英文原版FDA CVM GFI 200 is a guidance document provided by the U.S. Food and Drug Administration (FDA) for the development and approval of new animal drugs intended for use in small animals. This guidance document provides information on the regulatory requirements and procedures for the approval of new animal drugs. It covers various aspects of the drug development process, including preclinical studies, clinical studies, and issues related to safety and effectiveness.The guidance document begins by explaining the purpose and scope of the document. It states that the document is intendedto provide guidance to sponsors and applicants who wish to develop new animal drugs for use in small animals, such as dogs and cats. It also provides clarification on the regulatory requirements and expectations for the approval of such drugs.The document then discusses the preclinical development of new animal drugs. It highlights the importance of conducting adequate preclinical studies to assess the safety and effectiveness of the drug. These studies include pharmacologyand toxicology testing, which aim to determine the drug's mechanism of action, its potential side effects, and itspotential interactions with other drugs.Next, the guidance document discusses the design and conduct of clinical studies for new animal drugs. It emphasizes the need for well-designed and controlled studies to demonstrate thedrug's safety and effectiveness in the target animal population. It provides guidance on various aspects of clinical studies, including study design, sample size determination, inclusion and exclusion criteria, and evaluation of study endpoints.The document also addresses issues related to the safety and effectiveness of new animal drugs. It highlights the need for thorough safety evaluations, including the assessment of potential adverse effects and appropriate monitoring strategies. It also discusses the importance of demonstrating the drug's effectiveness through adequate and well-controlled clinical studies.Additionally, the guidance document provides information on the regulatory requirements for the submission and review of new animal drug applications. It discusses the types of applications that can be submitted, the content and format requirements for these applications, and the review process conducted by the FDA.Finally, the guidance document includes appendices that provide additional information and resources for sponsors and applicants. These appendices cover topics such as the use of controlled clinical trials, statistical considerations inclinical trials, and the FDA's approach to quality assurance for new animal drugs.。
仿生设计方法学
仿生设计方法学English:Biomimicry, also known as biomimetics, is a design method that takes inspiration from nature to solve human problems. This approach involves studying and understanding the efficient and sustainable solutions that already exist in the natural world and then applying those principles to design and innovation in various fields. Biomimicry involves looking at how a particular organism or natural process has evolved to perform a specific function and then applying those strategies to create new technologies, materials, and systems. This method of design is not only beneficial for creating more sustainable and environmentally friendly products, but it also leadsto innovative and efficient solutions that can significantly contributeto human progress.中文翻译:仿生学,又称仿生技术,是一种从自然中汲取灵感来解决人类问题的设计方法。
这种方法涉及研究和理解自然界中已经存在的高效和可持续的解决方案,然后将这些原则应用于各个领域的设计和创新。
1-10A manufacturer moving upstream
A manufacturer moving upstream:triadiccollaboration for service deliveryMax Finne and Jan Holmstro¨mDepartment of Industrial Engineering and Management,Aalto University,Aalto,FinlandAbstractPurpose–The purpose of this paper is to explore servitization in the context of the service supply chain,particularly the effects of the relationship between the subsystem supplier and the end user on the supplier’s as well as on the supply chain’s ability to provide industrial services.In addition,it aims to present a solution to overcome the challenges of lack of this relationship.Design/methodology/approach–A case study incorporating an explorative design science approach identifies a theoretically novel and practically relevant problem in thefield of service supply chain management.The study combines empirical data collection;systematic conceptualization of means and ends;evaluation of proposed solutions in iterative-and action-oriented cycles;and theoretical explanation of the observed phenomena and outcomes.Findings–By establishing a triadic operational model with an integrator and end user,the subsystem supplier can servitize within a supply chain in which the end user relationship is controlled by the integrator.This enables the combining of critical service provision capabilities:supplier’s maintenance-related capabilities and integrator’s end user access.Research limitations/implications–Further research is needed to determine the importance of managing the transition to subsystem suppliers in different types of industrial service supply chains.Because these observations and proposals are based on a single case study,the authors cannot draw conclusions as to how they apply to manufacturers in different problem situations.Practical implications–The paper presents a decision-making procedure that describes how a subsystem supplier opting for cooperation in the service supply chain can formulate a coherent set of triadic operational models with intermediaries and end users.Originality/value–The paper shows how servitization takes place on supply chain level.Keywords Service supply chains,Triads,Industrial services,Manufacturing industries,Supply chain managementPaper type Research paper1.IntroductionThe literature on servitization presents the reasons behind manufacturers moving toward offering industrial services and the associated operational challenges(see Wise and Baumgartner,1999;Oliva and Kallenberg,2003).The focus of previous studies has been on the service-providing manufacturer,its offering,and its end users.Accordingly, most service supply chains discussed in the literature are dyadic because they include only a service provider and its customers(Sampson,2000).However,in situations where manufacturers take on the role of systems integrator and solution provider(Davies and Brady,2000;Davies et al., 2007;Brax and Jonsson,2009),the collaboration of subsystem suppliers can be critical to the scope of the service offering and the effectiveness of the industrial service operations.While systems integrators working closely with end users have the best understanding of the service needs in general,subsystem suppliers possess critical capabilities and resources regarding service provision for their supplied subsystems(see Normann and Ramı´rez,1993).In this context,servitization takes place on the supply chain level and involves the subsystem supplier,integrator,and end user. This paper studies servitization in a service supply chain context.Furthermore,the paper focuses on the effects of the subsystem supplier’s lack of an end user relationship on industrial service provision in a service supply chain.Our research question is:how can the subsystem supplier design a solution enabling more effective industrial service provision in the supply chain when the end user relationship is controlled by a downstream party?A relationship with the end user is essential because end users also act as suppliers of necessary installed base information andfield service premises for industrial service production(see Sampson,2000). Therefore,when subsystem suppliers provide part of the total service to the end users,a supply chain transforms to a triad(Li and Choi,2009)in which all three parties involved–The current issue and full text archive of this journal is available at /1359-8546.htmSupply Chain Management:An International Journal18/1(2013)21–33q Emerald Group Publishing Limited[ISSN1359-8546] [DOI10.1108/13598541311293159]Received17February2011 Revised23June201117January201218April2012Accepted24April2012supplier,integrator,and end user–become interlinked to each other in direct relationships.The paper presents the empirical case of a manufacturer, HitechCo(the name is a pseudonym),which is struggling with its service operations in situations where it supplies subsystems to other manufacturers that control direct relationships with end users.The company’s challenge is to servitize in this upstream position.Previously,HitechCo was operating in dyads with end users and successfully offering them industrial services consisting of design and development;installation and commissioning;maintenance and repair;consulting;and modernizing.Because of the maturing product technology,the supply chain structure changed and integrators appeared between HitechCo and the end users.Regarding product sales,the new situation was not problematic.From the point of view of service operations, however,the situation changed dramatically for the worse.In the previous dyadic situation,the company had straight access to end users,whereas in the new situation,the end customer relationship was controlled by the integrators.Because HitechCo was determined to improve its ability to deliver industrial services,it decided to aim for continuing to act as a supplier of integrators while also building a relationship with end users,which implied a triadic operational model. Contrary to the servitization literature(Wise and Baumgartner,1999;Oliva and Kallenberg,2003),a manufacturer with a successful service business needs to adapt to systems integrators pushing it further upstream in some customer relationships.The process is driven by technological maturation(Arthur,2009).As a technology matures,the manufacturing cost tends to fall,which means that end users are not prepared to spend the same amount of time and effort in procuring,installing,and upgrading a particular type of system as when the technology was cutting-edge.Instead,systems integrators take over the role of combining subsystems into working solutions for the end user.Designing an effective service supply chain in this problem context is dependent on aligning the operations and interests of several parties that may also view each other as competitors(see Brandenburger and Nalebuff,1996). HitechCo’s challenge is to adapt a previously successful service business as the company is forced upstream by systems integrators and solution providers.As a subsystem supplier, the company aims to form a service supply chain with intermediaries and corporate end users.Intermediaries refer to both systems integrators and external service providers that operate in between suppliers and end users in the service supply chain.Systems integrators use the supplier’s product as a component in the equipment operated in industrial processes by the end users.The supplier,systems integrators, or external service providers provide industrial services.More than one party can participate in delivering maintenance, product support,and other industrial services to the end users.In the current situation,HitechCo has lost its previously unimpeded access to a significant proportion of end users.The company must focus its efforts of servitization on the needs and interests of intermediaries in order to achieve access to end users in a triadic cooperational model. HitechCo’s problems in industrial service delivery affect the whole service supply chain.The systems integrators lack expertise in the appropriate use and maintenance of the company’s products,which results in increased downtime and higher maintenance-related costs for the end users.The systems integrators’service resources lack essential capabilities because their products consist mostly of mechanical parts,while HitechCo’s products also have critical electrical components.The electrical components require different types of skills from the service engineers,as well as additional service facilities to carry out more demanding maintenance tasks.HitechCo’s products are investment goods used in various industrial processes to control the processes and to improve their efficiency in saving energy,for example.Unless HitechCo and its systems integrator customers can adjust operations,the efficiency and service capability of the service supply chain as a whole suffers.The structure of the paper is as follows:the next section is a literature review on servitization of manufacturing,the roles of supplier and integrator in the service supply chain,and the triadic nature of service supply chains.The research methodology is presented in section3,and the results in section4.The results section is divided into solution context, solution aim,and solution contents for four levels of collaboration for different situations and the procedure for selecting the appropriate collaboration level.Finally,the theoretical and practical implications of the research are given in the discussion and conclusion section,where the limitations of the study are also presented,and directions for future research are provided.2.Literature reviewThis section gives the literature background for our research that studies servitization in supply chains,particularly from the point of view of subsystem suppliers.First,the dominant dyadic focus of existing servitization studies is described. Second,the important role of subsystem suppliers in supporting integrators in service provision is analyzed. Third,the literature on service supply chains is reviewed, particularly with regard to their triadic nature.2.1Servitization of manufacturingThe role of manufacturing companies in service provision has been increasingly discussed in the literature.A downstream move to service business is viewed as a beneficial way to generate new business,increase profitability,and differentiate from competition(see Wise and Baumgartner,1999;Oliva and Kallenberg,2003).Vandermerwe and Rada(1988) termed this transition towards increasing service dominance “servitization.”The servitization literature has focused on discussing the reasons behind manufacturers’entering service operations(Cohen et al.,2006b;Baines et al.,2009b);the challenges involved(Brax,2005;Gebauer et al.,2005);the organizational changes required(Brax,2005;Johnstone et al., 2009),and the effects on company performance(Neely, 2008).The research has concentrated very much on the service-providing manufacturer and its dyadic relationship with the end user.The shift towards service operations requires manufacturers to focus on their relationship capabilities(Brax,2005; Prakash,2011).This requirement applies particularly to servitizing manufacturers of investment goods,like our case company HitechCo,because offering services for goods with longer life cycles necessitates closer partnerships with customers and emphasizes openness,trust,and long-term commitment(Johnsen et al.,2009).Some of these companies opt for providing performance-based contracts for investment goods.In order to ensure better performance,they need to cooperate very closely with their end users by being proactive andflexible(Datta and Roy,2011).According to Baines et al.(2011),this may imply that the manufacturers have to integrate vertically downstream.Traditionally,industrial services have been directly linked to the product,consisting of mainly maintenance and repair. Accordingly,in“product-centric servitization,”a service portfolio is directly coupled with the product offering (Baines et al.,2009a).More recently,servitization has also included relationship-related services.In line with this, Mathieu(2001)categorized the services provided by manufacturers as services supporting the manufactured product(SSP)and services supporting the client’s actions, with or without a direct link to their product(SSC). Studies on the effects of servitization on company performance have produced mixed results.Neely(2008) found that larger manufacturers in particular do not realize thefinancial benefits of servitization.On the other hand, Eggert et al.(2011)studied the effect of servitization on companies with different levels of product innovation activity. They found that SSPs directly increase long-term profitability for companies with high product innovation activity. However,their effect on low product innovation companies is only indirect.In addition,SSCs do not have any link to the profitability of companies with high product innovation activity,but they directly increase long-term profitability for low product innovation companies.Because of the dyadic focus of the servitization literature, the importance of the subsystem supplier’s involvement in service delivery has remained under-explored.The literature has emphasized the importance of the manufacturer’s control over downstream parties(Schmenner,2008),and some authors have even equated servitization with moving downstream(Wise and Baumgartner,1999).However,there is a dearth of research on how servitization takes place in supply chains.2.2Supplier and integrator roles in the service supply chainT o a great extent,service supply chain design determines how end users,intermediaries,and suppliers participate in service delivery.Baltacioglu et al.(2007,p.112)define the service supply chain as“the network of suppliers,service providers, consumers and other supporting units that performs the functions of transaction of resources required to produce services;transformation of these resources into supporting and core services;and the delivery of these services to customers.”Servitizing manufacturing companies can take the role of systems integrators in the service supply chain. This happens when they concentrate on solving customer problems with customized solutions,consisting of integrated products,services,and information(Davies and Brady,2000; Brax and Jonsson,2009).On the other hand,some manufacturers become suppliers of systems integrators, which happened to our case company HitechCo.Providers of integrated solutions are highly dependent on the specialized skills and capabilities of their suppliers.They have to rely on various technologies provided by specialized suppliers(Davies et al.,2006)and may also utilize suppliers in service provision to support the subsystem.For example,Brax and Jonsson(2009)described the reliance of a systems integrator on its software supplier in improving the efficiency of its industrial service operations.T o improve the overall efficiency of the company’s service operations,their case company was dependent on a software supplier further developing a software platform and increasing the automation of laborious tasks.Davies et al.(2007)found that the producers of complex investment goods transitioning into systems integration have to acquire new relationship capabilities and skills.Systems integrators carry the total responsibility of the projects delivered and focus on improving their partnering competence.However,at the same time,they rely more heavily on networks of specialized service suppliers to deliver components of the total system(Davies,2004).Suppliers of subsystems also need to develop new relationship-oriented skills(Galbraith,2002)in order to act effectively in service supply chains controlled by systems integrators and other intermediaries.The task is challenging, and requires an understanding of the processes of not only different system integrators but also end users.The level of trust between supplier and integrator also affects the type of skills required because systems integrators operate and maintain the systems delivered and coordinate the supply of services from suppliers(Davies et al.,2006;Johnsen et al., 2009).Based on market requirements and customer needs, key suppliers of services or products need to develop the capability of supporting the integrator effectively and operating at different levels of cooperation with the integrators and end users.The relationship between the subsystem supplier and end users is central in the study of the servitization of the supplier.Thereby,the service supply chain becomes essentially triadic.2.3Triadic nature of service supply chainsService supply chains differ from manufacturing supply chains in that they are more challenging and complex to manage(see Parasuraman et al.,1985)and triadic by nature (Choi and Wu,2009).In industrial service delivery, complexity is introduced by bidirectional operations (Sampson and Froehle,2006)in which the customer is a supplier of the asset to be maintained as well as the supplier of information on the use and performance of the asset. Furthermore,infield services,the customer provides the premises where part of the service operation is performed. Therefore,the supplier also establishes a relationship with the end user in industrial service provision,transforming the supply chain into a triad in which all three actors are directly connected to each other(Li and Choi,2009).The relationships among the actors in the triad affect each one;accordingly,the service supply chain should be regarded as a system(Aronsson et al.,2011;Gotzamani et al.,2010) whose efficiency is determined by a number of factors.The efficiency depends on how well the supply chain design is aligned with the structure and characteristics of the product, such as criticality and reliability(Cohen et al.,2006a). However,manufacturers need to take into account not only product considerations(Wang,2002;Jiang and Hansen, 2003)in the design of the service supply chain.On the demand side,the customer,customer relationship,and customer’s operational capability also shape the requirements of the supply chain structure(Collin et al., 2009;Giannakis,2011).Service supply chains are characterized by their triadic nature,which is caused by the direct relationships between the different actors.The nature of these relationships and the level of integration and trust among different actors are major determinants of the capability of the supply chain to deliver services(Meijboom et al.,2011;Bhakoo and Chan,2011).In product supply chains,a sequence of dyadic relationships among supply chain members is often sufficient.Service supply chains are different in this respect and exhibit a greaternumber of interrelationships(Rossetti and Choi,2008; Gotzamani et al.,2010);for example,service triads link suppliers not only to the integrator but also to the end user.A more complex triadic relationship becomes necessity,for example,in the maintenance of complex systems in which the intermediary is not certified to maintain parts of the system, and the service buyer must establish a relationship with both the intermediary and its supplier.This situation applies in the empirical case of HitechCo;its systems integrators do not have enough expertise to service its product completely.The challenge of organizing the service supply chain in multiple ways has been clearly recognized in the literature(see Sampson and Froehle,2006;Baltacioglu et al.,2007; Giannakis,2011).However,the tools and procedures for identifying and designing triadic service supply chains are lacking.Previous research(Wang,2002;Jiang and Hansen, 2003;Kaipia and Holmstro¨m,2007;Collin et al.,2009; Holmstro¨m et al.,2010)has focused on the distribution of work and responsibilities in dyadic relationships but does not deal appropriately with service triads.The remainder of the paper focuses on how a supplier of various systems integrators can deliver industrial services to end users by cooperating with the integrators in triadic operational models.The existing research on industrial service supply chains has studied the situation from a dyadic integrator-customer point of view.However,the whole triad deserves much more ing a case study design,we identify four different ways in which the supplier can cooperate with the integrator and end user to establish a relationship with the latter and therebyfill the structural hole (Li and Choi,2009)in the triad.The next section presents the research methodology of the empirical part of this study.3.MethodologyService supply chain design is a problem context where the interrelationships between manufacturer,heterogeneous intermediaries,and end users are complex,and therefore substantive theories are difficult to formulate.Because of the lack offield-tested theory,practitioners’success remains highly reliant on time-and money-consuming experimentation(Hayes et al.,2004).In such circumstances,design science research(see Sein et al., 2011)has been proposed as an approach for bridging practical design and exploration with theory development (Holmstro¨m et al.,2009).The purpose is to use iterative cycles of design,experimentation,and evaluation to identify new relevant problems and develop managerial decision-making tools that contribute to emerging streams of research in the academic domain.This research approach contributes to the body of scientific knowledge with elements of design theory,such as purpose and scope,form and function, testable propositions,demonstrations,principles of implementation,and theoretical justifications of the design (Gregor and Jones,2007).A fully developed design theory is field tested,and of high managerial relevance and strong theoretical grounding(van Aken,2004).The empirical research(see Figure1)followed a design science approach(Holmstro¨m et al.,2009).The design and field-testing of a proposed solution was carried out in an18-month longitudinal case study(Yin,2003).This research was carried out as part of a research project focusing on the service supply chains of global manufacturing companies.The initiative for the case study came from the organizational unit responsible for product support and service supply chain design of a manufacturer of investment goods.The case company,which we call“HitechCo,”is a global manufacturer that has service operations in over50countries.At the time when the research was initiated,the company was having difficulties with its service operations.It had previously been very successful in providing advanced industrial services directly to end users of its product.Primarily due to falling manufacturing costs,the case company found itself selling to systems integrators rather than end users.The systems integrators were operating in a number of industries,such as oil and gas,pulp and paper,and metal.Some provided product-related services consisting of maintenance and repair, whereas others did not provide any services whatsoever.When researchers contacted HitechCo,the problem situation was fuzzy and identified as being related to service provision in the systems integrators’channel.After preliminary interviews,the researchers were able to define the problem:how to deal best with various intermediaries with a wide range of different business interests and a varying ability to provide required end-user services.Following a design science approach for exploration (Holmstro¨m et al.,2009),the goal of the case study was to identify and define new relevant problems in thefield, propose and test solutions,and theoretically explain the observed outcomes.In particular,the subsystem supplier’s relationship with the end users was identified as crucial for industrial service provision in a supply chain,and a solution was developed to overcome the challenges caused by the lack of this relationship.We combined empirical data collection, systematic conceptualization of means and ends,and evaluation of the proposed solutions in iterative and action-oriented cycles.The problem description and solution proposal presented in the results section are the result of the iterative presentation and interpretation of the primary data collected in thefield.The iterative process of solution design, development,evaluation,andfield-testing was continued as long as new insights and changes to the proposed solution could be achieved.The data collection and analysis was carried out according to the design science approach in an iterative process consisting of two main phases(see Figure1).First,the initially ill-structured problem situation of the company regarding service provision in the systems integrators’channel was analyzed to define the problem and develop an initial proposal for a solution.HitechCo’s inability to deliver industrial services efficiently was identified as contingent on the lack of end user relationships controlled by systems integrators.The proposed solution aimed to address this problem by offering HitechCo ways to cooperate with intermediaries in order to achieve the critical access to end users and therebyfill the structural hole in the triad.Second, the proposed solution was evaluated and refined in an iterative process in which piloting validated the refined solution. Piloting incorporated people not participating in the earlier phases in the evaluation and refinement of the solution proposal to avoid a self-evaluation bias.The primary data, which is described in detail in the Appendix(see T ables AI-AIII),consist of thematic interviews,meetings,and workshops with HitechCo employees;pilots with HitechCo’s other business units and original equipment manufacturer (OEM)customers(i.e.systems integrators);HitechCo’s internal documents and presentations;data on delivered products;and observations at HitechCo’s premises during two four-month on-site research periods.The24thematic interviews that were carried out lasted30to120minutes;theinterview themes are presented in T able I.In total,14 interviews were recorded and transcribed.Overviews of all of the interviews were written and sent to the interviewees to verify the contents.Additional interviews were carried out until theoretical saturation was reached(i.e.when no new information emerged).The interview data were triangulated with company internal documents whenever possible.The empirical research process started with phase1a(see Figure1).This phase included seven interviews with HitechCo’s service managers in order to develop an understanding of the current problem situation in their service operations,and thus define the research problem.Two interviews with representatives of successful industrial service providers from other industries(T oyota and SKF)were also carried out to benchmark best practices.After defining the problem,ten more interviews were carried out in phase1b, which determined the HitechCo employees responsible for different aspects of the systems integrators in order to develop an initial candidate for the solution.Five interviews with HitechCo’s OEM customers(i.e.systems integrators)wereTable I Interview themes in research phases1a and1bPhase1a interviews:problem definition Phase1b interviews:solution formulationInformation managementInstalled base and related information Information sharing in the supply chain Information managementInstalled base information available from HitechCo’s systems Information sharing in the supply chainCustomers and offeringCustomer segments and customer needsProduct and service offerings for different customers OEM customers in interviewee’s responsibility area OEM customer characteristics in the responsibility area Offerings for OEM customers in the area HitechCo’s relationship with specific OEM customersOEM customersOEM customer characteristicsExisting services for OEM customersOEM customers’service strategiesPossible new services for the OEM customers Incubation of the devised solutionCurrent way to divide between different kinds of OEMs Service business potential in the OEM channelSupply chain managementSpare part deliveries and logistics Warranty servicesService deliveryBiggest challenges in the current situation Specification of the devised solutionHitechCo’s policies regarding services for its productsPossible ways to carry out maintenance on different parts of HitechCo’s products Possible criteria for segmenting the OEM customersPossible new services for the OEM customersRoles of different parties in the service delivery to OEMsNew ideas through benchmarkingHitechCo internal best practicesNew service development practices in other industries Integrator’s viewpoint on the solution Benefits of the solution to the OEM Challenges of the solution to the OEMFigure1Empirical researchprocess。
上限效果假说主要内容
上限效果假说主要内容
上限效果假说,又称为Effort Decrement主要是指在某一段时间内,在勤奋和努力的基础上,不断增加时间或费用大到一定程度后,效果将变得越来越小,甚至变得无效果。
这一理论的提出来源于西德经济学家的研究。
它首次被称为上限效应曲线,旨在探讨投入增加后产出的增加速度是否会逐渐变慢。
上限效果假说建立在经济分析之上,主要讨论投入超过一定程度后,较多的投入将会导致收益缩减。
它也表明增加投入本身不会完全抵消投入增加带来的成本,也不会得到完全的增量收益,因此,当投入达到最高值时,收益也就达到最大点。
上限效果假说可以被用来预测市场趋势。
从理论上说,如果市场上的某种产品的投入超过一定程度后,那么它的产出也会受到限制,其市场价格也就可以预测出来。
此外,从管理的角度来看,上限效果假说也能够帮助企业管理者更好地把握投入与收益的比率,使企业投入得到更大的回报。
上限效果假说也可以被用于社会管理和政策制定中。
社会管理者可以借此运用有效的方法,以防止投入过多,同时也要及时调整更多投入,以获得更好的绩效收益。
此外,在政策制定上,政府必须考虑到上限效果假说,以保持政策的有效性,并有助于政策的有效执行。
总的来说,上限效应假说是一种有效的效率和行为分析理论,它指出在投入某种资源时,投入增加到一定程度后,所获得的收益可能会越来越小,甚至达不到预期的收益。
它可以用来让市场管理者把握
自身投入和收益的比率,因此,运用上限效果假说可以提高企业的效率和绩效。
此外,它也可以用于社会管理和政策制定,以确保政策的有效性。
关于路面实验的 外国文献
Contents ScienceDirect
Construction and Building Materials
journal homepage: /locate/conbuildmat
Evaluation of the induction healing effect of porous asphalt concrete through four point bending fatigue test
Quantao Liu a,⇑, Erik Schlangen a, Martin van de Ven b, Gerbert van Bochove c, Jo van Montfort d
article info
Article history: Received 8 July 2011 Received in revised form 19 September 2011 Accepted 2 October 2011 Available online 29 November 2011
Ó 2011 Elsevier Ltd. All rights reserved.
1. Introduction
Netherlands is a densely populated country and many people live close to the motorways, so traffic noise is one of the most serious environmental issues. To reduce traffic noise, porous asphalt was first utilized as a surface wearing course in 1972 and it was decided to start applying porous asphalt surface wearing courses on a larger scale in 1987 [1,2]. Up to now, close to 90% of the Dutch motorway networks is surfaced with porous asphalt concrete and it is a government policy to apply porous asphalt on the whole motorway network [3]. Standard porous asphalt PA 0/16 is used mostly as a surface wearing course with a thickness of 50 mm and a minimum air voids content of 20%. This open structure can reduce traffic noise by 3 db [4,5]. Besides, porous asphalt also reduces spray and splash and prevents aquaplaning under wet conditions, which can improve the driving comfort and safety [6,7].
ICH-GCP中英文对照(完整)
ICH-GCP中英文对照(完整)ICH 三方协调指导原则 E6 ICH GCP指导原则INTRODUCTION前言Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.临床试验管理规范(GCP)是设计、实施、记录和报告设计人类对象参加的试验国际性伦理和科学质量标准。
遵循这一标准为保护对象的权利、安全性和健康,为与源于赫尔辛基宣言的原则保持一致以及临床试验数据的可信性提供了公众保证。
The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by theregulatory authorities in these jurisdictions. ICH-GCP指导原则的目的是为欧盟、日本和美国提供统一的标准,以促进这些管理当局在其权限内相互接受临床数据。
美国药效研究实施方案英文
美国药效研究实施方案英文The Implementation Plan for Pharmaceutical Efficacy Research in the United StatesPharmaceutical efficacy research is a crucial aspect of the healthcare system in the United States. It plays a vital role in ensuring the safety and effectiveness of medications that are available to the public. In order to carry out pharmaceutical efficacy research effectively, a comprehensive implementation plan is essential. This plan should encompass various aspects, including research methods, regulatory requirements, and ethical considerations. In this document, we will outline a detailed implementation plan for pharmaceutical efficacy research in the United States.First and foremost, it is important to establish clear research objectives and goals. These objectives should be aligned with the overall mission of ensuring public health and safety. Research objectives may include evaluating the efficacy of new medications, comparing the effectiveness of different treatment options, or assessing the long-term effects of pharmaceutical interventions. By clearly defining research objectives, the implementation plan can be tailored to meet specific research needs and priorities.In addition to setting research objectives, it is essential to select appropriate research methods and study designs. Pharmaceutical efficacy research often involves clinical trials, observational studies, and meta-analyses. Each research method has its own strengths and limitations, and the choice of method should be based on the specific research question and available resources. For example, clinical trials are ideal for evaluating the efficacy of new medications, while observational studies may be more suitable for assessing real-world treatment outcomes.Furthermore, regulatory requirements and ethical considerations are integral components of the implementation plan for pharmaceutical efficacy research. In the United States, pharmaceutical research is subject to strict regulations set forth by the Food and Drug Administration (FDA). Researchers must adhere to these regulations to ensure the safety and ethical conduct of research involving human subjects. Additionally, ethical considerations such as informed consent, confidentiality, and data integrity must be carefully addressed in the implementation plan.Another important aspect of the implementation plan is therecruitment and retention of research participants. Patient recruitment is often a challenging aspect of pharmaceutical efficacy research, and strategies for identifying and enrolling eligible participants should be clearly outlined in the plan. Moreover, efforts to minimize participant attrition and ensure compliance with study protocols should be addressed to maintain the integrity and validity of research findings.In order to effectively implement the pharmaceutical efficacy research plan, collaboration and communication among stakeholders are essential. This includes collaboration between researchers, healthcare providers, regulatory agencies, and industry partners. Clear communication channels should be established to facilitate the exchange of information, data sharing, and dissemination of research findings.Lastly, the implementation plan should include a comprehensive approach to data analysis, interpretation, and reporting. Data analysis methods should be carefully selected to ensure the validity and reliability of research findings. Furthermore, the interpretation of research results should be communicated in a clear and transparent manner, and research findings should be disseminated throughpeer-reviewed publications and scientific conferences.In conclusion, the implementation plan for pharmaceutical efficacy research in the United States is a multifaceted endeavor that requires careful planning and coordination. By addressing research objectives, methods, regulatory requirements, ethical considerations, participant recruitment, collaboration, and data analysis, the implementation plan can effectively guide the conduct of high-quality pharmaceutical efficacy research. Through the rigorous implementation of this plan, the healthcare system in the United States can continue to advance and improve the safety and effectiveness of medications for the benefit of the public.。
政策、法规及治疗准则——研究人员呼吁美国FDA进行改革
政策、法规及治疗准则——研究人员呼吁美国FDA进行改革陈舒意(摘)
【期刊名称】《国外药讯》
【年(卷),期】2006(000)007
【摘要】美国范德比尔特大学的Ray和Stein等人近日在《新英格兰医学杂志》撰文指出,美国FDA应建立三个新的独立中心,来承担许多目前由公司进行的管理任务,而建立这些中心的资金应源于药品销售的税收。
由于“无为的代价是不能被接受的”,而每一次新的药物灾难都破坏了公共卫生基础设施的可信度,因而对FDA进行改革便成为必要。
FDA在Merck公司的Vioxx撤市后,于去年2月成立了新的药物安全监督委员会,但并未解决FDA药品管理体系中所存在的很多重要缺陷。
这些缺陷包括:上市后数据评价中利益的冲突、药品厂商的过度影响。
他们认为药物安全监督委员会缺少权力、资源和相对FDA的独立性。
【总页数】1页(P1)
【作者】陈舒意(摘)
【作者单位】无
【正文语种】中文
【中图分类】R95
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Under the infinitesimal gauge transformation δn ˆ = −α × n ˆ , δ Aµ = one has [4,5] δAµ = 1 ˆ µ α, ˆµ = 1 D n ˆ · ∂µ α, δ A g g δ Xµ = − α × Xµ . (4) 1 Dµ α, g (3)
Recently Faddeev and Niemi have discovered the knot-like topological solitons in the Skyrme-type nonlinear sigma model [1], and made an interesting conjecture that the Skyrme-Faddeev action could be interpreted as an effective action for QCD in the low energy limit [2]. On the other hand it is generally believed that QCD in the low energy limit must exhibit the confinement of color, and it has long been argued that the confinement could take place through the condensation of the monopole which generates the dual Meissner effect [3,4]. So, in order to reconcile the Faddeev-Niemi conjecture with the confinement, one must be able to construct the effective action of QCD from the first principles and produce the mass scale that the Skyrme-Faddeev action contains, which could demonstrate the dynamical symmetry breaking and triggers the confinement of color in QCD [4,5]. However, a rigorous derivation of an effective action of QCD which could generate the desired monopole condensation has been extremely difficult [6,7]. Fortunatly several authors have recently been able to argue that one can indeed derive a generalized SkyrmeFaddeev action from the effective action of QCD in the infra-red limit, at least in some approximation [8,9]. The purpose of this paper is to study the FaddeevNiemi conjecture in more detail. Our analysis shows that, after the monopole condensation, the effective action of QCD could be approximated around the new vacuum by a generalized Skyrme-Faddeev action. Furthermore, our analysis strongly indicates that the mass scale in the Skyrme-Faddeev action is closely related to the confinement scale in QCD. This establishes a deep connection between a generalized Skyrme-Faddeev type non-linear sigma model and QCD which is remarkable. On the other hand the assertion that the Skyrme-Faddeev action could describe QCD in the infra-red limit is found to be misleading. In particular, it is highly unlikely that the Faddeev-Niemi knots can be realized in QCD.
Faddeev-Niemi Conjecture and Effective Action of QCD
Y. M. Cho1 , H. W. Байду номын сангаасee2 , and D. G. Pak3,4
Department of Physics, College of Natural Sciences, Seoul National University, Seoul 151-742, Korea 2) Department of Physics, College of Natural Sciences, Chungbuk University, Chungju, Korea 3) Asia Pacific Center for Theoretical Physics, 207-43 Cheongryangri-dong, Dongdaemun-gu, Seoul 130-012, Korea 4) Department of Theoretical Physics, Tashkent State University, Tashkent 700-095, Uzbekistan
where Aµ is the “electric” potential. Notice that the ˆµ is precisely the connection which Abelian projection A leaves n ˆ invariant under the parallel transport, ˆ µn ˆµ × n D ˆ = ∂µ n ˆ + gA ˆ = 0. 1 (2)
To study a dynamical symmetry breaking induced by the monopole condensation one must first calculate the effective action of QCD under the monopole background. To do this one has to integrate out all the dynamical degrees of the non-Abelian gauge theory, leaving only the monopole configuration as the background. For this it is necessary for us to identify the monopole potential, and separate it from the generic QCD connection, in a gauge independent manner. This can be done with the gaugeindependent decomposition of the non-Abelian gauge potential into the dual potential and the valence potential [4,5], which provides us a natural reparameterization of the non-Abelian connection in terms of the dual potential of the maximal Abelian subgroup H of the gauge group G and the gauge covariant vector field of the remaining G/H degrees. With this decomposition one can calculate the effective action of QCD using the background field method, and show that the monopole condensation takes place after one integrates out all the dynamical degrees of the non-Abelian gauge potential. For simplicity we will consider SU (2) QCD. A natural way to identify the monopole potential and to separate the topological degree is to introduce an isotriplet unit vector field n ˆ which selects the color direction at each space-time point, and to decompose the connection into the Abelian projection which leaves n ˆ invariant and the remaining part which forms a covariant vector field [4,5], 1 ˆµ + Xµ , Aµ = Aµ n ˆ− n ˆ × ∂µ n ˆ + Xµ = A g (Aµ = n ˆ · Aµ , n ˆ 2 = 1, n ˆ · Xµ = 0), (1)