文档介绍：ICH Q8(中英文)
blueski推荐 [2009-12-20]
出处:Julia的blog
作者:不详
 
INTERNATIONAL CONFERENCE ON HARMONISATION 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 Harmonised Tripartite Guideline  ICH三方协调指南
Pharmaceutical Development药物开发
Q8
mended for Adoption at Step 4 of the ICH Process on 10 November 2005 by the ICH mittee      ICH指导委员会2005年11月10日ICH第四阶段推荐采用
  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 mended for adoption to the regulatory bodies of the European Union, Japan and USA. 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。 
TABLE OF CONTENTS目录
 
1.       INTRODUCTION简介... 1
     Objective of the Guideline指南目的... 1
     Scope范围... 1
2.       PHARMACEUTICAL DEVELOPMENT药物开发... 1
     Components of the Drug Product制剂产品的组分... 4
      Drug Substance活性成分... 4
      Excipients辅料... 4
     Drug Product制剂... 5
      Formulation Development配方开发... 5
      Overages超量... 6
      Physicochemical and Biological Properties物化和生化性质... 7
     Manufacturing Process Development制造工艺开发... 7
     Container Closure System容器系统... 9
     Microbiological Attributes微生物属性... 9
     Compatibility兼容性... 10
3.       GLOSSARY术语... 11
1.    INTRODUCTION 简介
Objective of Guideline 指南目的
This guideline describes the suggested contents for the (Pharmaceutical Development) section of a regulatory submission in the ICH mon Technical Document (CTD) format.  本指南就 CTD 章:药物开发需要叙述的内容给出了建议。
The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its manufacturing process. It is first prod