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 a
ICH-GCP中英文对照Tag内容描述：
1、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。
2、 Q7a（ 中英文对照 ） FDA 原料药 GMP 指南 Table of Contents 目录 1. INTRODUCTION 1. 简介 1.1 Objective 1.1 目的 1.2 Regulatory Applicability 1.2 法规的适用性 1.3 Scope 1.3 范围 2. QUALITY MANAGEMENT 2.质量管理 2.1 Principles 2.1 总则 2.2 Responsibilities of the Quality Unit(s) 2.2 质量部门的责任 2.3 Responsibility for Production Activities 2.3 生产作业的职责 2.4 Internal Audits (Self Inspection) 2.4 内部审计（自检） 2.5 Product Quality Review 2.5 产品质量审核 3. PERSONNEL 3. 人员 3.1 Personnel Qu。
3、Q7a（中英文对照 ）FDA 原料药 GMP 指南Table of Contents 目录1. INTRODUCTION 1. 简介1.1 Objective 1.1 目的1.2 Regulatory Applicability 1.2 法规的适用性1.3 Scope 1.3 范围2. QUALITY MANAGEMENT 2.质量管理2.1 Principles 2.1 总则2.2 Responsibilities of the Quality Unit(s) 2.2 质量部门的责任2.3 Responsibility for Production Activities 2.3 生产作业的职责2.4 Internal Audits (Self Inspection) 2.4 内部审计（自检）2.5 Product Quality Review 2.5 产品质量审核3. PERSONNEL 3. 人员3.1 Personnel Qualifications 3.。
4、Page 1 of 28PHARMACEUTICAL QUALITY SYSTEMQ10制药质量体系Q10Current Step 4 version dated 4 June 2008 当前版本，2008年6 月4日，第4步TABLE OF CONTENTS 目录1. PHARMACEUTICAL QUALITY SYSTEM 1制药质量体系1.1 Introduction 11绪论1.2 Scope 12范围1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7.13ICHQ10与地方GMP要求，ISO 标准与ICHQ7之间的关系1.4 Relationship of ICH Q10 to Regulatory Approaches14ICHQ10与法规方法间的关系1.5 ICH Q10 Objectives 15ICHQ10目的1.5.1 Achieve Produ。
5、ICHQ7A(原料药 GMP 生产指南)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 for Human 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 。
6、 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 da。
7、 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 。
8、 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 da。
