FDAGMPICH临床实验专业英语词汇互译文档格式.docx

1、preparing and submitting:起草和申报submission:申报;递交benefit（s）:受益risk（s）:受害drug product:药物产品drug substance:原料药established name:确定的名称generic name:非专利名称proprietary name:专有名称;INN（international nonproprietary name）:国际非专有名称narrative summary:记叙体概要adverse effect:副作用adverse reaction:不良反应protocol:方案archival copy:存

2、档用副本review copy:审查用副本official compendium:法定药典（主要指USP, NF）.USP（the united state pharmacopeia）:美国药典（现已和NF合并一起出版）NF（national formulary）美国）国家药品集official=pharmacopeial = compendial:药典的;法定的;官方的agency:审理部门（指FDA）sponsor:主办者（指负责并着手临床研究者）identity:真伪;鉴别;特性strength:规格;规格含量（每一剂量单位所含有效成分的量）labeled amount:标示量regul

3、atory specification:质量管理规格标准（NDA提供）regulatory methodology:质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation:管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement:食用补充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Huma

4、n Use）人用药物注册技术要求国际协调会议ICHuality-质量Q1A（R2）: Stability Testing of New Drug Substances and Products （Second Revision）新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs f

5、or Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV,药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validati

6、on of Analytical Procedures: Methodology分析程序的验证:方法学Q3A（R）: Impurities in New Drug Substances （Revised Guideline）新原料药中的杂质（修订版）Q3B（R）: Impurities in New Drug Products （Revised Guideline）新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质:残留溶剂指南Q3C（M）: Guideline for Residual Solvents （Mainte

7、nance）残留溶剂指南（修改内容）Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Bi

8、otechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Stability Testing of Biotechnological/Biological Products生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Use

9、d for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specification

10、s: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质Q6B: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products生物技术/生物产品的检验程序和可接收标准-作者:月萝兰魂发布时间:2006-12-22 13:34:00Q7: Good Manufacturing Pr

11、actices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH:Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指

12、南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C（R）: Addendum: Addition of a Limit Dose and Related Notes附录:极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals

13、受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals基因毒性:药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissu

14、e Distribution Studies药物代谢动力学:重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals （Rodent and Non-Rodent Toxicity Testing）动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B（M）: Maintenanc

15、e of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products对男性生殖能力的毒性的指南的变动:药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology

16、 Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization（QT Interval Prolongation） By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3（M）: Maintenance of the IC

17、H Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行

18、临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting临床安全数据管理:速报制度的定义和标准E2B（R）: Revision of the E2B（M） ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M）的修订版E

19、2B （M）: Maintenance of the Clinical Safety Data Management including: Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括:个案安全报告送交的数据要素E2B（M）: Maintenance of the Clinical Safety Data Management including Questions and Answers临床安全数据管理的变动,包括问答E2C: Periodic Safety Update Repor

20、ts for Marketed Drugs已上市药品的周期性安全数据更新报告Addendum to E2C:E2C的附录:E2D: Post-Approval Safety Data Management:批准后的安全数据管理:E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量-效应资料E5: Ethnic Fac

21、tors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP:良好的临床规范:统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究:老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinic

22、al Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation

23、of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information （ESTRI）药政信息传递之电子标准M3: Timing of Pre-clinical Stu

24、dies in Relation to Clinical Trials （See Safety Topics）有关临床试验的临床前研究的时间安排M4: The Common Technical Document （See CTD section for complete Status of the guidelines）通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP: time-to-progression疾病进展时间SAE: severity Ad

25、verse Event严重不良事件AE: Adverse Event不良事件SOP: Standard Operating Procedure标准操作规程CRF: Case Report form病例报告表DLT:剂量限制毒性MTD:最大耐受剂量KPS: Karnofsky Performance Status行为状态评分CR: complete response完全缓解PR: partial response部分缓解SD:病情稳定PD: progressive disease病情进展CTC:常用药物毒性标准IEC: independent ethics committee独立伦理委员会IRB

26、 : institutional review board伦理委员会CRA:临床研究助理CRO: Contract Research Organization合同研究组织DFS: Disease Free Survival无病生存期OS: （Overall Survival）总生存时间IC: Informed consent知情同意ADR: Adverse Drug Reaction不良反应GAP:Good Agricultural Practice中药材种植管理规范Good Clinical Practice药物临床试验质量管理规范GLP:Good Laboratory Practice药品

27、实验室管理规范GMP:Good Manufacturing Practice药品生产质量管理规范GSP:Good Supply Practice药品经营质量管理规范GUP:Good Use Practice药品使用质量管理规范PIrincipal investigator主要研究者CI: Co-inveatigator合作研究者SI :Sub-investigator助理研究者COI :Coordinating investigtor协调研究者DGMP:医疗器械生产质量管理规范ICF: Informed consent form知情同意书RCT : randomized controlled trial,随机对照试验NRCCT: non-randomized concurrent controlled trial,非随机同期对照试验EBM: evidence-based medicine循证医学RCD: randomized cross-over disgn随机交叉对照试验HCT: his