FDA-GMP-ICH临床实验专业英语词汇互译.docx

此文档收集于网络，如有侵权请联系网站删除electronic adj. 电子的bridegroom n. 新郎 vt. 减轻（痛苦；忧虑）FDA常用词中英对照 FDA(food and drug adminisration)：(美国)食品药品监督管理局NDA(new drug application)：新药申请 ANDA(abbreviated new drug application)：简化新药申请 EP(export application)：出口药申请(申请出口不被批准在美国销售的药品) treatment IND：研究中的新药用于治疗 abbreviated(new)drug：简化申请的新药 DMF(drug master file)：药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备,加工,包装和贮存过程中所涉及的设备,生产过程或物品.只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND, NDA,ANDA时才能参考其内容) holder：DMF持有者 CFR(code of federal regulation)：(美国)联邦法规 PANEL：专家小组 batch production：批量生产;分批生产 batch production records：生产批号记录 post or pre-market surveillance：销售前或销售后监督 informed consent：知情同意(患者对治疗或受试者对医疗试验了解后表示同意接 受治疗或试验)prescription drug：处方药 OTC drug(overthecounter drug)：非处方药 U.S. public health service：美国卫生福利部 NIH(national institute of health)：(美国)全国卫生研究所 animal trail：动物试验 accelerated approval：加速批准 standard drug：标准药物 investigator ：研究人员;调研人员preparing and submitting：起草和申报 submission：申报;递交 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 regulatory 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 Human Use)人用药物注册技术要求国际协调会议ICH：Quality-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 for 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： Validation 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)： Impurities： Guideline for Residual Solvents (Maintenance)杂质：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 Biotechnological 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： Quality of Biotechnological Products： Stability Testing of Biotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D： Derivation and Characterisation of Cell Substrates Used 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： Specifications： 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： Specifications： Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7： Good Manufacturing Practices 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 Tissue 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)： Maintenance 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 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 ICH 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E2B (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： Clinical Safety Data Management： Periodic Safety Update Reports for Marketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C： Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D： Post-Approval Safety Data Management： Definitions and Standards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准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 Factors 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 Clinical 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 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 Studies 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 Adverse 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 ： 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 GCP：Good Clinical Practice 药物临床试验质量管理规范 GLP：Good Laboratory Practice 药品实验室管理规范 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PI ：Principal 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： historial control trial, 历史对照研究RECIST： Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC： Quality Control质量控制UADR： Unexpected Adverse Drug Reaction,非预期药物不良反应GMP英语PIC/S的全称为：Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S) PIC的权威翻译：药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药 又称：活性药物组分AirLock 气闸 Authorized Person 授权人 Batch/Lot 批次 Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area洁净区;Consignmecnt(Delivery)托销药品.ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse Event AIM Active Ingredient Manufacturer ANDA Abbreviated New Drug Application ANOVA Analysis of Variance ASM： Active Substance ManufacturerATC Anatomical Therapeutic Chemical ATX Animal Test Exemption Certificate BANBritish Approved Name BIRABritish Institute of Regulatory Affairs BNF British National Formulary BP British Pharmacopoeia C of A Certificate of Analysis C of S Certificate of Suitability CENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA) CMS Concerned Member State CMS每个成员国 COS Certificate of Suitability CPMP Committee for Proprietary Medicinal Products CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organisation CTA Clinical Trial Application CTC Clinical Trial Certificate CTD Common Technical Document CTX Clinical Trials Exemption DDD Defined Daily Dose DGC Daily Global Comparison DIA Drug Information Association DMF Drug Master File Drug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会 EEA 欧洲经济地区EGMA European Generics Medicine Association ELA Established Licence Application EMEA European Medicines Evaluation Agency EMEA (European Agency for the Evaluation of Medicinal Products) 欧洲联盟药品评价机构EP European Pharmacopoeia EPAR European Public Assessment Reports ESRA European Society of Regulatory Affairs European Pharmacopoeia Commission 欧洲药典委员会FDA Food and Drug Administration final evaluation report (FER)free sale certificates (FSCs) Health Sciences Authority (HSA)HSAs Medicines Advisory Committee (MAC)IB Investigators Brochure ICH International Conference for Harmonisation IDMC Independent Data-Monitoring Committee IEC Independent Ethics Committee IND Investigational New Drug INN International Non-proprietary Name International Conference on Harmonisation (ICH) IPC In Process Control IRB Institutional Review Board LICENCE HOLDERMA Marketing Authorisation MAA Marketing Authorisation Application MAA上市申请 MAH Marketing Authorisation Holder MAH 销售许可持有者MCA Medicines Control Agency MHW Ministry of Health and Welfare (Japan) MR Mutual Recognition MRA 美国与欧盟的互认协议 MRAs (Mutual Recognition Agreements) 互相认证同意MRFG Mutual Recognition Facilitation Group MRPMutual Recognition Procedure NASNew Active Substance NCENew Chemical Entity NDANew Drug Application new chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory Drug NTA Notice To Applicants OOS Out of Specification OTC Over The Counter PAGB Proprietary Association of Great Britain Ph Eur European Pharmacopoeia PIL Patient Information Leaflet PL Product Licence POM Prescription Only Medicine PRODUCT OWNERPSU Periodic Safety Updates QA Quality Assurance QC Quality Control RAJ Regulatory Affairs Journal RMS Reference Member State RMS相互认可另一成员国 RSD Relative Standard Deviation Rx Prescription Only SAE Serious Adverse Event SMF Site Master File SOP Standard Operating Procedure SOP (STANDARD OPERATION PROCEDURE) 标准运作程序SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US Pharmacopoeia VMF Veterinary Master File VPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会(美国)ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典 ICH 安全性领域常用专业术语中英文对照表Dead offspring at birth 出生时死亡的子代Degradation 降解 Delay of parturition 分娩延迟Deletion 缺失 Descriptive statistics 描述性统计 Distribution 分布Detection of bacterial mutagen 细菌诱变剂检测 Detection of clastogen 染色体断裂剂检测Determination of metabolites 测定代谢产物 Development of the offspring 子代发育Developmental toxicity 发育毒性 Diminution of the background lawn 背景减少Direct geneti