FDA_GMP_ICH临床实验专业英语词汇互译

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(over—the—counter 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GMP
Q7A：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 Drugs
E2C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 Guideline
GCP：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 Manufacturer
ATC 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, CPA
EDQM (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)
HSA's 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 HOLDER
MA 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 OWNER
PSU 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 Committee
A.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 genetic damage 直接遗传损伤
DNA adduct DNA加合物DNA damage DNA损伤
DNA repair DNA修复DNA strand breaks DNA链断裂
Dose escalation 剂量递增Dose dependence 剂量依赖关系Dose level 剂量水平
Dose-limiting toxicity 剂量限制性毒性Dose-raging studies 剂量范围研究
Dose-relatived mutagenicity 剂量相关性诱变性Dose-related 剂量相关
Dose-relatived cytotoxicity 剂量相关性细胞毒性
Dose-relatived genotoxic activity 剂量相关性遗传毒性
Dose-response curve 剂量-反应曲线Dosing route 给药途径
Duration 周期Duration of pregnancy 妊娠周期
Eaning 断奶Earlier physical malformation 早期躯体畸形
Early embryonic development 早期胚胎发育
Early embryonic development to implantation 着床早期的胚胎发育
Electro ejaculation 电射精
Elimination 清除
Embryofetal deaths 胚胎和胎仔死亡Embryo-fetal development 胚胎-胎仔发育
Embryo-fetal toxicity 胚胎-胎仔毒性Embryonic death 胚胎死亡
Embryonic development 胚胎发育Embryonic period 胚胎期
Embryos 胚胎Embryotoxicity 胚胎毒性
Enantiomer 对映异构体
End of pregnancy 怀孕终止Endocytic 内吞噬(胞饮)
Endocytic activity 内吞噬活性Endogenous proteins 内源性蛋白
Endogenous components 内源性物质Endogenous gene 内源性基因
Endonuclease 核酸内切酶Emdpmiclease release from lysosomes 溶酶体释放核酸内切酶End-point 终点
Epididymal sperm maturation 附睾精子成熟性Epitope 抗原决定部位
Error prone repair 易错性修复Escalation 递增
Escherichia coli strain 大肠杆菌菌株Escherichia coli 大肠杆菌
Evaluation of test result 试验结果评价
Exaggerated pharmacological response 超常增强的药理作用
Excretion 排泄(清除) Exposure assessment 接触剂量评价
Exposure period 接解期External metabolizing system 体外代谢系统
F1-animals 子一代动物
False positive result 假阳性结果
Fecundity 多产Feed-back 反馈Fertilisation 受精Fertility 生育力
Fertility studies 生育力研究Fetal abnormalities 胎仔异常
Fetal and neonatal parameters 胎仔和仔鼠的生长发育参数
Fetal development and growth 肿仔发育和生长Fetal period 胎仔期Fetotoxicity 胎仔毒性False negative result 假阴性结果First pass testing 一期试验
Fluorescence in situ hybridization(FISH) 原位荧光分子杂交
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