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Validation of Analytical Procedures: Text REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药品的注册要求 ICH HARMONISED TRIPARTITE GUIDELINE ICH协调的三方指导原则 VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY 分析方法验证：正文和方法学 Q2(R1) Current Step 4 version 现行第4阶段版本 Parent Guideline dated 27 October 1994 最初指导原则起于1994年10月27日 (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。 Validation of Analytical Procedures: Text Q2(R1) Document History Q2(R1) 文件历史 First Codification 初次法典化 History 历史 Date 时间 New Codification November 2005 Parent Guideline: Text on Validation of Analytical Procedures 最初的指导原则：分析方法的验证 Q2 Approval by the Steering Committee under Step 2 and release for public consultation. 在第2阶段经策划委员会批准，作为公用的咨询 26 October 2003 2003-10 Q2 Q2A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 在第4阶段经侧环委员会同意并推荐给三方ICH监管机构采用 27 October 1994 1994-10-27 Q2 Guideline on Validation of Analytical Procedures: Methodology developed to complement the Parent Guideline 分析方法验证的指导原则：扩展的方法学作为最初指导原则的补充 Q2B Approval by the Steering Commit...