ich中英文

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ICH概述

CH共召开了10次国际性大会，具体情况见下表：
时间
举办地
参会人数
1200 1500 2400 1600 1700 1800
1991.11 布鲁塞尔，比利时 1993.10 佛罗里达，美国 1995.11 横滨，日本 1997.07 布鲁塞尔，比利时 2000.11 圣地亚哥，美国 2003.11 大阪，日本 2007.11 东京，日本 2008.11 华盛顿，美国 2009.06 东京，日本
4. ICH工作的特征和目标（1）病人第一一切从病人利益出发是ICH讨论和协商的基础，决定技术文件的准则是：“是否有利于病人？如何才能更快地为病人提供高质量、安全有效的药物？如何才能按国际标准进行高质量的临床试验？” （2）对话和协作管理部门和工业部门的专家在同一原则下进行讨论，从不同角度提出更合理的见解，避免片面性。在ICH会议中，管理部门和工业部门是对话，不是对抗；是相互合作和相互信任，不是互相扯皮。
3.2 工作程序 ICH把需讨论专题的进展分为5个阶段：（1）阶段1：EWG技术讨论专家工作组对新选题目进行初步讨论，并起草出初稿，初稿可以是建议（Recommendation）、政策说明（Policy Statement）、指导原则（Guide-line）或讨论要点（Points to Consider）等形式。由专家工作组对初稿进行讨论、审查和修改，直到达成共识，提交指导委员会。（2）阶段2：达成共识由指导委员会的六个主办单位负责人对初稿进行审查讨论后签字，提交欧、美、日三方药品管理部门正式讨论，在六个月内将意见汇总。
---日本厚生劳动省，Ministry of Health、Labour and Welfare，Japan (MHW)
---日本制药工业协会，Japan Pharmaceutical Manufacturers Association (JPMA)

ich药学术语

ich药学术语"Ich" 是指国际药品注册合作组织（International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use），通常简称为ICH。

ICH 是一个国际性的组织，由来自欧洲、日本和美国的药品监管机构以及制药行业的代表组成，致力于制定和推动全球范围内药品注册和药品开发的技术规范的一致性。

以下是与ICH 相关的一些药学术语：●ICH指导方针(ICH Guidelines): ICH 制定的关于药品开发、注册和监管的技术指南，以确保全球范围内的一致性。

●QbD (Quality by Design):一种质量管理方法，强调在产品开发的早期阶段就考虑质量。

●CTD (Common Technical Document): 一种标准化的文件格式，用于提交药品注册文件，是ICH 指导方针的一部分。

●GMP (Good Manufacturing Practice):良好生产规范，是确保药品生产过程中质量的基本要求。

●ICH GCP (Good Clinical Practice): 临床实验的良好临床实践指南，规定了进行人体试验的伦理和质量标准。

●ICH Efficacy Guidelines: ICH关于药物疗效性能的指导方针，包括临床试验和疗效性评估的要求。

●ICH Safety Guidelines: ICH关于药物安全性的指导方针，包括药物的不良反应监测和评估的要求。

●ICH M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities inPharmaceuticals to Limit Potential Carcinogenic Risk): ICH发布的关于评估和控制药物中DNA反应性（诱变性）杂质的指导方针。

ICH临床部分术语中英文对照表

ICH临床部分术语表active comparator treatment 阳性对照治疗 active dose 有效剂量active placebo treatment 阳性安慰剂治疗active treatment concurrent control 阳性药物并行对照adaptive allocation 适应性分组法 addendum 附件add-on study 在标准治疗基础上的对照试验adjust dosage 调整剂量adjustments for covariates 协变量调整administration instruction 用药指南administrative criteria 用药标准 adoption 采用adverse consequence 不良后果 adverse drug events (ADE) 药物不良事件adverse drug reaction (ADR) 药物不良反应adverse event (AE) 不良事件adverse experience 不良经验 alert event 警告事件allocation with sites 临床试验点分配法Amendment (to the protocol) 修改（试验方案）ANCOVA 协方差分析agonist 激动剂antagonist 拮抗剂applicable laws and regulations 适用的法律和法规applicable regulatory requirement 适用的管理条例application dossier 申报资料 approval 批准approved for marketing 批准上市assay sensitivity 检测方法的灵敏度assessment 评估audit 稽查audit certificate 稽查证书audit report 稽查报告audit trail 稽查过程authorization renewal 授权更新authorized 授权 authorized with qualification 颁发许可证average dose-response curve 平均量效曲线backup of the data 数据备份baseline-controlled studies 基线对照研究 batch number 批号bayesian approaches 贝叶斯方法benefit/risk ratio 利益／风险比例bias 偏差 biometrics 生物统计birth defect 出生缺陷 blind review 盲态检查blinding 盲法 blinding/masking 设盲block design 区组设计blood-level peaks 血药峰值brand name 商品名 break the blind 破盲bridging data package 跨越数据集 bridging study 跨越研究bulk sales 批量销售 carcinogenicity 致癌carry-over effect 持续效应 case report form(CRF) 病例报告表categorical variable 分类变量 causal relationship 因果关系centralised allocation 集中分配法change from baseline response 基线反应变换法 CIOMS 国际医学科学组织理事会clinical drug development 临床药物开发 clinical response 临床反应clinical safety 临床安全性clinical safety data management 临床安全性资料管理clinical safety infomation 临床安全性信息clinical trial/study 临床试验/研究combination therapy 联合治疗committee for proprietary medical products 专利医药产品委员会company core data sheet (CCDS) 公司核心资料表company core safety information(CCSI) 公司核心安全性信息comparability of test groups 试验组间的可比性comparative effectiveness studies 有效性的比较研究comparator 对照剂comparator(product) 对照（药物）compassionate use 照顾性应用 complete clinical data package 完整的临床资料集compliance 依从性compounds insensitive to ethnic factors 对种族因素不敏的药物concentration-response values 浓度—效应值concentration-controlled study 浓度控制研究concentration-response relationship 浓度—效应关系concomitant medications 伴随用药concurrent control 并行对照confidentiality 保密性confirmatory study 确认性研究congenital abnormaly 先天性异常consent form 知情同意书content validity 内容的确实性contract 合同contract research organization (CRO) 合同研究机构contraindication 禁忌证control drug 对照药controlled trials 对照试验controlled vocabularies 对照词汇Coordinating Committee 协调委员会coordinating investigator 协调研究者copies appended 副本country entries 参与国家的名单covariate effect 协受欢应cox regression output 回归分析criteria for the termination of the trial 终止试验的标准crossover control 交叉对照crossoverr design 交叉设计 cross-over study 交叉研究cross-referencing 交叉参阅 CTX number CIX编号cumulative dose 蓄积剂量data base 数据库data element 数据要素data entry and processing 数据输入和处理data lock point 数据锁定点demographic characteristics 人口学特征direct access 直接接触documentation 文件dosage 剂量dosage form 剂型 dosage strength 规格。

ICH指导原则

ICH指导原则ICH简介：ICH原为International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use（人用药品注册技术要求国际协调会），现已更名为The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use（人用药品技术要求国际协调理事会），简称ICH（国际协调理事会）。

Quality Guidelines质量Q1 Stability（稳定性）Q2 Analytical Validation（分析方法验证）Q3 Impurities（杂质）Q4 Pharmacopoeias（药典）Q5 Quality of Biotechnological Products（生物技术产品的质量）Q6 Specifications（质量标准）Q7 Good Manufacturing Practice（生产质量管理规范）Q8 Pharmaceutical Development（药品研发）Q9 Quality Risk Management（质量风险管理）Q10 Pharmaceutical Quality System（药物质量体系）Q11 Development and Manufacture of Drug Substances（原料药而研发和生产）Q12 Lifecycle Management（生命周期管理）Safety Guidelines安全性S1 Carcinogenicity Studies（致癌性研究）S2 Genotoxicity Studies（遗传毒性研究）S3 Toxicokinetics and Pharmacokinetics（毒代动力学和药代动力学）S4 Toxicity Testing（毒性试验）S5 Reproductive Toxicology（生殖毒性）S6 Biotechnological Products（生物技术药品）S7 Pharmacology Studies（药理学研究）S8 Immunotoxicology Studies（免疫毒性研究）S9 Nonclinical Evaluation for Anticancer Pharmaceuticals（抗癌药物的非临床研究）S10 Photosafety Evaluation（光安全性研究）S11 Nonclinical Safety Testing（非临床安全性试验）Efficacy Guidelines有效性E1 Clinical Safety for Drugs used in Long-Term Treatment（长期用药的临床安全性）E2 Pharmacovigilance（药物警戒）E3 Clinical Study Reports（临床研究报告）E4 Dose-Response Studies（量-效关系研究）E5 Ethnic Factors（种族因素）E6 Good Clinical Practice（药物临床研究质量管理规范）E7 Clinical Trials in Geriatric Population（老年人群的临床试验）E8 General Considerations for Clinical Trials（临床试验的一般考虑）E9 Statistical Principles for Clinical Trials（临床试验的统计原则）E10 Choice of Control Group in Clinical Trials（临床试验中对照组的选取）E11 Clinical Trials in Pediatric Population（儿童用药品的临床试验）E12 Clinical Evaluation by Therapeutic Category（新抗高血压药的临床评价）E14 Clinical Evaluation of QT（QT临床评价）E15 Definitions in Pharmacogenetics / Pharmacogenomics（药物遗传学/药物基因组学的定义）E16 Qualification of Genomic Biomarkers（基因组生物标记物的条件）E17 Multi-Regional Clinical Trials（国际多中心临床试验）E18 Genomic Sampling（基因组采样）Multidisciplinary Guidelines多学科综合M1 MedDRA Terminology（监管活动医学术语）M2 Electronic Standards（电子标准）M3 Nonclinical Safety Studies（非临床安全性研究）M4 Common Technical Document（通用技术文件）M5 Data Elements and Standards for Drug Dictionaries（药物词汇的数据要素和标准）M6 Gene Therapy（基因治疗）M7 Genotoxic Impurities（基因毒性杂质）M8 Electronic Common Technical Document (eCTD)（电子通用技术文件）M9 Biopharmaceutics Classification System-based Biowaivers（基于生物药剂学分类系统的生物豁免）M10 Bioanalytical Method Validation（生物样品分析的方法验证）有效性(Efficacy Guidelines)。

ICH临床部分术语中英文对照表

ICHQ2(R1)中英文对照

incorporated to the parent guideline.
The new title is “Validation of
Analytical Procedures: Text and
Methodology”. 最初的指导原则现在更名为Q2(R1)因为指导原则Q2B方法学已经合并到最初的指导原则中。新标题“分析方法验证：
Q2 Approval by the Steering 26 October
Q2
Committee under Step 2 and 2003
release for public consultation. 在第2阶段经策划委员会批准，作为公用的咨询
2003-10
Q2A Approval by the Steering 27 October
(Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)
（方法学补充指导原则完成于1996年11月6日，于2005年11月合并）
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 此指导原则由适当的 ICH 专家工作组起草，经调整团磋商，于 ICH 过程一致。在第四阶段，最终的草案推荐给欧盟，日本和美国的监管机构采用。

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 the regulatory 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。

ICH 三方协调指导原则 E6 ICH GCP 【中英文对照】

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 the regulatory 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。

ICH中英文对照版本

人用药物注册技术要求国际协调会议( I C H ：International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals forHuman Use)ICH三方协调指南原料药的优良制造规范（GMP）指南ICH指导委员会2000年11月10日按ICH规程第4步建议采用本指南根据ICH规程由合适的ICH专家工作组起草并经向法规部门咨询。

在规程的第4步，建议欧洲共同体、日本和美国的药政部门采用其最终的草案。

原料药的优良制造规范（GMP）指南ICH三方协调指南ICH指导委员会2000年11月10日的会议按ICH规程第4步建议ICH的三个药政部门采用本指南目录1 引言INTRODUCTION (6)1.1 目的Objective (6)1.2 法规的适用性Regulatory Applicability (7)1.3 范围Range (7)2 质量管理QUALITY MANAGEMENT (8)2.1 原则Principles (8)2.2 质量部门的职责Responsibilities of the Quality Unit(s) (9)2.3 生产作业的职责Responsibility for Production Activities (11)2.4 内部审计（自检）Internal Audits (Self Inspection) (12)2.5 产品质量审核Product Quality Review (12)3 人员PERSONNEL (13)3.1 员工的资质Personnel qualifications (13)3.2 员工的卫生Personnel Hygiene (13)3.3 顾问Consultants (14)4 建筑和设施BUILDINGS AND FACILITIES (14)4.1 设计和结构Design and Construction (14)4.2 公用设施Utilities (15)4.3 水Water (16)4.4 限制Containment (16)4.5 照明Lighting (17)4.6 排污和垃圾Sewage and Refuse (17)4.7 清洁和保养Sanitation and Maintenance (17)5 工艺设备PROCESS EQUIPMENT (17)5.1 设计和结构Design and Construction (18)5.2 设备保养和清洁Equipment Maintenance and Cleaning (18)5.3 校验Calibration (19)5.4 计算机控制系统Computerized Systems (20)6 文件和记录DOCUMENTA TION AND RECORDS (21)6.1 文件系统和规格Documentation System and Specifications (21)6.2 设备的清洁和使用记录Equipment Cleaning and Use Record (22)6.3 原料、中间体、原料药的标签和包装材料的记录Records of Materials , Intermediates, API Labeling andPackaging Materials (22)6.4 生产工艺规程Master Production Instructions (23)6.5 批生产记录Batch Production Records (24)6.6 实验室控制记录Laboratory Control Records (25)6.7 批生产记录审核Batch Production Record Review (26)7 物料管理MA TERIALS MANAGEMENT (26)7.1 控制通则General Controls (26)7.2 接收和待验Receipt and Quarantine (27)7.3 进厂物料的取样和测试Sampling and Testing of Incoming Production Materials (27)7.4 储存Storage (28)7.5 重新评估Re-evaluation (29)8 生产和中间控制PRODUCTION AND IN-PROCESS CONTROLS (29)8.1 生产操作Production Operations (29)8.2 时间限制Time Limits (30)8.3 工序间的取样和控制In-process Sampling and Controls (30)8.4 中间体或原料药的混合Blending Batches of Intermediates or APIs (31)8.5 污染的控制Contamination Control (32)9 原料药和中间体的包装和贴签PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES (32)9.1 总则General (32)9.2 包装材料Packaging Materials (33)9.3 标签的发放和控制Labeling Issuance and Control (33)9.4 包装和贴签操作Packaging and Labeling Operations (34)10 储存和分发STORAGE AND DISTRIBUTION (35)10.1 入库程序Warehousing Procedures (35)10.2 分发程序Distribution Procedures (35)11 实验室控制LABORATORY CONTROLS (35)11.1 控制通则General Controls (35)11.2 中间体和原料药的测试Testing of Intermediates and APIs (37)11.3 分析程序的验证－参见12章V alidation of Analytical Procedures - See Section 12. (11.3) (38)11.4 分析报告单Certificates of Analysis (38)11.5 原料药的稳定性监测Stability Monitorint of APIs (38)11.6 有效期和复验日期Expiry and Retest Dating (39)11.7 留样Reserve/Retention Samples (40)12 验证V ALIDATION (40)12.1 验证方针Validation Policy (40)12.2 验证文件Validation Documentation (41)12.3 确认Qualification (41)12.4 工艺验证的方法Approaches to Process Validation (42)12.5 工艺验证的程序Process Validation Program (43)12.7 清洗验证Cleaning V alidation (44)12.8 分析方法的验证Validation of Analytical Methods (45)13 变更的控制CHANGE CONTROL (45)14 物料的拒收和再用REJECTION AND RE-USE OF MATERIALS (46)14.1 拒收Rejection (47)14.2 返工Reprocessing (47)14.3 重新加工Reworking (47)14.4 物料和溶剂的回收Recovery of Materials and Solvents (48)14.5 退货Returns (48)15 投诉和召回COMPLAINTS AND RECALLS (49)16 协议制造商(包括实验室) CONTRACT MANUFACTURES (INCLUDING LABORATORIES) (49)17 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者 (50)AGENTS,BROKERS, TRADERS,DISTRIBUTORS,REPACKERS ,AND RELABELLERS (50)17.1 适用性Applicability (50)17.2 已分发原料药的可追溯性Traceability of Distributed APIs and Intermediates (50)17.3 质量管理Quality Management (51)17.4 原料药和中间体的重新包装、重新贴签和待检Repackaging,Relabeling,and Holding of APIs and Intermediates. (51)17.5 稳定性Stability (51)17.6 信息的传达Transfer of Information (51)17.7 投诉和召回的处理Handing of Complaints and Recalls (52)17.8 退货的处理Handing of Returns (52)18 用细胞繁殖/发酵生产的原料药的特殊指南 (53)SPECIFIC GUIDANCE FOR APIs MANUFACTURED BY CELL CULTURE/FERMENTATION (53)18.1 总则General (53)18.2 细胞库的维护和记录的保存Cell Bank Maintenance and Record Keeping (55)18.3 细胞繁殖/发酵Cell Culture/Fermentation (55)18.4 收取、分离和精制Harvesting, Isolation and Purifation (56)18.5 病毒的去除/灭活步骤Viral Removal/Inactivation Steps (57)19 用于临床研究的原料药(APIS FOR USE IN CLINICAL TRIALS) (57)19.1 总则General (57)19.2 质量quality (58)19.3 设备和设施Equipment and Facilities (58)19.4 原料的控制Control of Raw Materials (58)19.5 生产Production (59)19.6 验证Validation (59)19.7 变更Changes (59)19.8 实验室控制Laboratory Controls (59)19.9 文件Documentation (60)20. 术语表（GLOOSSARY） (60)原料药的优良制造规范(GMP) 指南Guidance for IndustryQ7A Good Manufacturing Practice Guidancefor Active Pharmaceutical IngredientsThis guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.1 引言INTRODUCTION1.1 目的Objective本文件(指南)旨在为在合适的质量管理体系下制造活性药用成分(原料药以下称原料药)提供有关优良药品生产管理规范（GMP）提供指南。

FDA,GMP,ICH临床实验专业英语词汇互译

FDA,GMP,ICH临床实验专业英语词汇互译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)holderMF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 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-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--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-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--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 rincipal 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-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--GMP英语PIC/S的全称为harmaceutical 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 IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBANBritish Approved NameBIRABritish Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug 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 AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products) 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)Health Sciences Authority (HSA)HSA's Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 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 ProcedureNASNew Active SubstanceNCENew Chemical EntityNDANew Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (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 PharmacopoeiaVMF Veterinary Master FileVPC 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-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--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-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--average deviation 平均差Bbar chart 直条图,条图bias 偏性binomial distribution 二项分布biometrics 生物统计学bivariate normal population 双变量正态总体Ccartogram 统计图case fatality rate(or case mortality) 病死率census 普查chi-sguare(X2) test 卡方检验central tendency 集中趋势class interval 组距classification 分组,分类cluster sampling 整群抽样coefficient of correlation 相关系数coefficient of regression 回归系数coefficient of variability(or coefficieut of variation) 变异系数collection of data 收集资料column 列(栏)combinative table 组合表combined standard deviation 合并标准差combined variance(or poolled variance) 合并方差complete survey 全面调查completely correlation 完全相关completely random design 完全随机设计confidence level 可信水平,置信水平confidence limit 可信限,置信限constituent ratio 构成比,结构相对数continuity 连续性control 对照control group 对照组coordinate 坐标correction for continuity 连续性校正correction for grouping 归组校正correction number 校正数correction value 校正值correlation 相关,联系correlation analysis 相关分析correlation coefficient 相关系数critical value 临界值cumulative frequency 累积频率Ddata 资料degree of dispersion 离散程度degree of freedom 自由度degree of variation 变异度dependent variable 应变量design of experiment 实验设计deviation from the mean 离均差diagnose accordance rate 诊断符合率difference with significance 差别不显著difference with significance 差别显著discrete variable 离散变量dispersion tendency 离中趋势distribution 分布,分配-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Eeffective rate 有效率eigenvalue 特征值enumeration data 计数资料equation of linear regression 线性回归方程error 误差error of replication 重复误差estimate value 估计值event 事件experiment design 实验设计experiment error 实验误差experimental group 实验组extreme value 极值Ffatality rate 病死率field survey 现场调查fourfold table 四格表freguency 频数freguency distribution 频数分布GGaussian curve 高斯曲线geometric mean 几何均数grouped data 分组资料Hhistogram 直方图homogeneity of variance 方差齐性homogeneity test of variances 方差齐性检验hypothesis test 假设检验hypothetical universe 假设总体Iincidence rate 发病率incomplete survey 非全面调检indepindent variable 自变量indivedual difference 个体差异infection rate 感染率inferior limit 下限initial data 原始数据inspection of data 检查资料intercept 截距interpolation method 内插法interval estimation 区间估计inverse correlation 负相关Kkurtosis coefficient 峰度系数Llatin sguare design 拉丁方设计least significant difference 最小显著差数least square method 最小平方法,最小乘法leptokurtic distribution 尖峭态分布leptokurtosis 峰态,峭度linear chart 线图linear correlation 直线相关linear regression 直线回归linear regression eguation 直线回归方程link relative 环比logarithmic normal distribution 对数正态分布logarithmic scale 对数尺度lognormal distribution 对数正态分布lower limit 下限Mmatched pair design 配对设计mathematical statistics 数理统计(学) maximum value 极大值mean 均值mean of population 总体均数mean square 均方mean variance 均方,方差measurement data 讲量资料median 中位数medical statistics 医学统计学mesokurtosis 正态峰method of least squares 最小平方法,最小乘法method of grouping 分组法method of percentiles 百分位数法mid-value of class 组中值minimum value 极小值mode 众数moment 动差,矩morbidity 患病率mortality 死亡率Nnatality 出生率natural logarithm 自然对数negative correlation 负相关negative skewness 负偏志no correlation 无相关non-linear correlation 非线性相关non-parametric statistics 非参数统计normal curve 正态曲线normal deviate 正态离差normal distribution 正态分布normal population 正态总体normal probability curve 正态概率曲线normal range 正常范围normal value 正常值normal kurtosis 正态峰normality test 正态性检验nosometry 患病率-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Oobserved unit 观察单位observed value 观察值one-sided test 单测检验one-tailed test 单尾检验order statistic 顺序统计量ordinal number 秩号ordinate 纵坐标Ppairing data 配对资料parameter 参数percent 百分率percentage 百分数,百分率percentage bar chart 百分条图percentile 百分位数pie diagram 园图placebo 安慰剂planning of survey 调查计划point estimation 点估计population 总体,人口population mean 总体均数population rate 总体率population variance 总体方差positive correlation 正相关positive skewness 正偏态prevalence rate 患病率probability 概率,机率probability error 偶然误差proportion 比,比率prospective study 前瞻研究prospective survey 前瞻调查public health statistics 卫生统计学Qquality eontrol 质量控制quartile 四分位数Rrandom 随机random digits 随机数字random numbers table 随机数目表random sample 随机样本random sampling 随机抽样random variable 随机变量randomization 随机化randomized blocks 随机区组,随机单位组randomized blocks analysis of variance 随机单位组方差分析randomized blocks design 随机单位组设计randomness 随机性range 极差,全距range of normal values 正常值范围rank 秩,秩次,等级rank correlation 等级相关rank correlation coefficent 等级相关系数rank-sum test 秩和检验ranked data 等级资料rate 率ratio 比recovery rate 治愈率registration 登记regression 回归regression analysis 回归分析regression coefficient 回归系数regression eguation 回归方程relative number 相对数relative ratio 比较相对数relative ratio with fixed base 定基比remainder error 剩余误差replication 重复retrospective survey 回顾调查Ridit analysis 参照单位分析Ridit value 参照单位值Ssample 样本sample average 样本均数sample size 样本含量sampling 抽样sampling error 抽样误差sampling statistics 样本统计量sampling survay 抽样调查scaller diagram 散点图schedule of survey 调查表semi-logarithmic chart 半对数线图semi-measursement data 半计量资料semi-guartile range 四分位数间距sensitivity 灵敏度sex ratio 性比例sign test 符号检验significance 显著性,意义significance level 显著性水平significance test 显著性检验significant difference 差别显著simple random sampling 单纯随机抽样simple table 简单表size of sample 样本含量skewness 偏态slope 斜率sorting data 整理资料sorting table 整理表sources of variation 变异来源square deviation 方差standard deviation(SD) 标准差standard error (SE) 标准误standard error of estimate 标准估计误差standard error of the mean 均数的标准误standardization 标准化standardized rate 标化率standardized normal distribution 标准正态分布statistic 统计量statistics 统计学statistical induction 统计图statistical inference 统计归纳statistical map 统计推断statistical method 统计地图statistical survey 统计方法statistical table 统计调查statistical test 统计表statistical treatment 统计检验stratified sampling 统计处理stochastic variable 分层抽样sum of cross products of 随机变量deviation from mean 离均差积和sum of ranks 秩和sum of sguares of deviation from mean 离均差平方和superior limit 上限survival rate 生存率symmetry 对称(性)systematic error 系统误差systematic sampling 机械抽样-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Tt-distribution t分布t-test t检验tabulation method 划记法test of normality 正态性检验test of one-sided 单侧检验test of one-tailed 单尾检验test of significance 显著性检验test of two-sided 双侧检验test of two-tailed 双尾检验theoretical frequency 理论频数theoretical number 理论数treatment 处理treatment factor 处理因素treatment of date 数据处理two-factor analysis of variance 双因素方差分析two-sided test 双侧检验two-tailed test 双尾检验type I error 第一类误差type II error 第二类误差typical survey 典型调查Uu test u检验universe 总体,全域ungrouped data 未分组资料upper limit 上限Vvariable 变量variance 方差,均方variance analysis 方差分析variance ratio 方差比variate 变量variation coefficient 变异系数velocity of development 发展速度velocity of increase 增长速度Wweight 权数weighted mean 加权均数Zzero correlation 零相关-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:36:00--世界500强制药企业名称中英对照排名公司名称中文名称总部收入百万美元77 Pfizer 辉瑞美国 45950.092 Johnson & Johnson 强生美国 41862.0114 GlaxoSmithKline 葛兰素史克英国 35050.9193 Novartis 诺华瑞士 24864.0205 Roche Group 罗氏瑞士 23212.9222 Merck 默克美国 22485.9239 Bristol-Myers Squibb 百时美施贵宝美国 20894.0 248 Aventis 安万特法国 20162.4254 Abbott Laboratories 雅培美国 19680.6269 AstraZeneca 阿斯利康英国 18849.0330 Wyeth 惠氏美国 15850.6433 Eli Lilly 礼来大药厂美国 12582.5100 BASF 巴斯夫德国 37757.0125 Dow Chemical 道化学美国 32632.0129 Bayer 拜耳德国 32331.1365 Akzo Nobel 阿克苏诺贝尔荷兰 14770.7。

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INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMA N U S EICHH ARMONISED T RIPARTITE G UIDELINEG OOD M ANUFACTURING P RACTICE G UIDEFOR A CTIVE P HARMACEUTICAL I NGREDIENTSQ7CurrentStep4versiondated10November2000ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbyt heregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforad optiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.中英文对照Q7CurrentStep4versionOOD ANUFACTURING RACTICE UIDEFOR CTIVE HARMACEUTICAL NGREDIENTSICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon10November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH TableofContents目录1.INTRODUCTION1.前言1.1Objective1.1目的1.2RegulatoryApplicability1.2法规的适用性1.3Scope1.3范围2.QUALITYMANAGEMENT2.质量管理2.1Principles2.1总则2.2ResponsibilitiesoftheQualityUnit(s)2.2质量部门的责任2.3ResponsibilityforProductionActivities2.3生产的职责2.4InternalAudits(SelfInspection)2.4内部审计（自检）2.5ProductQualityReview2.5产品质量回顾3.PERSONNEL3.人员3.1PersonnelQualifications3.1人员资格3.2PersonnelHygiene3.2个人卫生3.3Consultants3.3顾问4.BUILDINGSANDFACILITIES4.建筑和设施4.1DesignandConstruction4.1设计和建造4.2Utilities4.2公用设施4.3Water4.3水4.4Containment4.4特殊限制4.5Lighting4.5照明4.6SewageandRefuse4.6污物和废弃物4.7SanitationandMaintenance4.7卫生和维护5.PROCESSEQUIPMENT5.工艺设备5.1DesignandConstruction5.1设计和建造5.2EquipmentMaintenanceandCleaning5.2设备维护和清洁5.3Calibration5.3校验5.4ComputerizedSystems5.4计算机控制系统6.DOCUMENTATIONANDRECORDS6.文件和记录6.1DocumentationSystemandSpecifications6.1文件系统和质量标准6.2EquipmentcleaningandUseRecord6.2设备的清洁和使用记录6.3RecordsofRawMaterials,Intermediates,6.3原料、中间体、原料药的标签和包装材料的记录APILabelingandPackagingMaterials6.4MasterProductionInstructions6.4主生产指令（主生产和控制记录）(MasterProductionandControlRecords)6.5BatchProductionRecords6.5批生产记录（批生产和控制记录）(BatchProductionandControlRecords)6.6LaboratoryControlRecords6.6实验室控制记录6.7BatchProductionRecordReview6.7批生产记录审核7.MATERIALSMANAGEMENT7.物料管理7.1GeneralControls7.1一般要求7.2ReceiptandQuarantine7.2接收和待验7.3SamplingandTestingofIncomingProductionMaterials7.3来料的取样与检测7.4Storage7.4储存7.5Re-evaluation7.5再评价8.PRODUCTIONANDIN-PROCESSCONTROLS8.生产管理和生产过程控制8.1ProductionOperations8.1生产管理8.2TimeLimits8.2时限8.3In-processSamplingandControls8.3生产过程中的取样和控制8.4BlendingBatchesofIntermediatesorAPIs8.4中间体或原料药的混批8.5ContaminationControl8.5污染控制9.PACKAGINGANDIDENTIFICATION9.原料药和中间体的包装和贴签LABELINGOFAPIsANDINTERMEDIATES9.1General9.1通则9.2PackagingMaterials9.2包装材料9.3LabelIssuanceandControl9.3标签发放与管理9.4PackagingandLabelingOperations9.4包装和贴签管理10.STORAGEANDDISTRIBUTION10.储存和分发10.1WarehousingProcedures10.1入库程序10.2DistributionProcedures10.2分发程序BORATORYCONTROLS11.实验室管理11.1GeneralControls11.1通则11.2TestingofIntermediatesandAPIs11.2中间体和原料药的检测11.3ValidationofAnalyticalProcedures11.3分析方法的验证11.4CertificatesofAnalysis11.4检验报告11.5StabilityMonitoringofAPIs11.5原料药的稳定性考察11.6ExpiryandRetestDating11.6有效期和复验期11.7Reserve/RetentionSamples11.7留样12.VALIDATION12.验证12.1ValidationPolicy12.1验证方针12.2ValidationDocumentation12.2验证文件12.3Qualification12.3确认12.4ApproachestoProcessValidation12.4工艺验证的方法12.5ProcessValidationProgram12.5工艺验证的程序12.6PeriodicReviewofValidatedSystems12.6对已验证的系统的定期回顾12.7CleaningValidation12.7清洗验证12.8ValidationofAnalyticalMethods12.8分析方法的验证13.CHANGECONTROL13.变更控制14.REJECTIONANDRE-USEOFMATERIALS14.物料的拒收和再利用14.1Rejection14.1拒收14.2Reprocessing14.2返工14.3Reworking14.3重新加工14.4RecoveryofMaterialsandSolvents14.4物料与溶剂的回收14.5Returns14.5退货PLAINTSANDRECALLS15.投诉与召回16.CONTRACTMANUFACTURERS16.协议生产商（包括实验室）(INCLUDINGLABORATORIES)17.AGENTS,BROKERS,TRADERS,DISTRIBUTORS,17.代理商、经纪人、贸易商、经销商、重新包装者REPACKERS,ANDRELABELLERS和重新贴签者17.1Applicability17.1适用性17.2TraceabilityofDistributedAPIsandIntermediates17.2已分发的原料药和中间体的可追溯性17.3QualityManagement17.3质量管理17.4Repackaging,Relabeling,andHoldingofAPIsandIntermediates17.4原料药和中间体的重新包装、重新贴签和待检17.5Stability17.5稳定性17.6TransferofInformation17.6信息的传达17.7HandlingofComplaintsandRecalls17.7投诉和召回的处理17.8HandlingofReturns17.8退货的处理18.SpecificGuidanceforAPIsManufacturedbyCell18.用细胞繁殖/发酵生产的原料药的特殊指南Culture/Fermentation18.1General18.1总则18.2CellBankMaintenanceandRecordKeeping18.2细胞库的维护和记录的保存18.3CellCulture/Fermentation18.3细胞繁殖/发酵18.4Harvesting,IsolationandPurification18.4收取、分离和精制18.5ViralRemoval/Inactivationsteps18.5病毒的去除/灭活步骤19.APIsforUseinClinicalTrials19.用于临床研究的原料药19.1General19.1总则19.2Quality19.2质量19.3EquipmentandFacilities19.3设备和设施19.4ControlofRawMaterials19.4原料的控制19.5Production19.5生产19.6Validation19.6验证19.7Changes19.7变更19.8LaboratoryControls19.8实验室控制19.9Documentation19.9文件20.Glossary20.术语1.INTRODUCTION1.简介1.1Objective1.1目的Thisdocumentisintendedtoprovideguidanceregardinggoodmanufacturingpractice(GMP)forthemanufacturingofactivepharmaceuticali ngredients(APIs)underanappropriatesystemformanagingquality.ItisalsointendedtohelpensurethatAPIsmeetthequalityandpuritycharac teristicsthattheypurport,orarerepresented,topossess.本文件旨在提供在适当的体系下为了控制生产原料药的质量而实施的药品生产质量管理规范（GMP）的指南。