CTD格式目录 ICH CTD-Table of ContentTable of Content ofICHCTD Module 1: Administrative Information and Prescribing Information 1.1Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common ...
2002) ICH 指导委员会会议ICH 进程第4 步 2000 年11 月9 日 该指南建议三方法规处采用ICH 2002 年9 月11-12 日华盛顿会议一致通过采用统一编号和标题并在e-CTD 中使用 i The Common Technical Document - Quality TABLE OF CONTENTS 目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 6 2.3 : QUALITY OV...
参考法规:1.M4: The Common Technical Document, ich.org/page/ctd2.FDA The Comprehensive Table of Contents Headings and Hierarchy, fda.gov/media/76444/dow 因文件信息量较多,清晰版PDF导图原文件,可后台私信领取。 此文为原创文章,对以上观点,有任何不妥之处,欢迎大家积极斧正,评论留言交流。 更多其他资讯...
, Clinical (Module 5)Overview/Summaries., 2.1 CTDTable of Contents , 2.2 CTD Introduction , 2.3 Qual ityOveral l Summary , 2.4 Non-cl inical Overview , 2.5 Cl inical Overview , 2.6 Non-cl inical Written andTabulated Summary , Pharmacology , Pharmacokinetics , Toxicology , 2.7...
化学仿制原料药CTD格式申报资料撰写要求-新旧CTD格式对比(原料药部分) 热度: INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICAL REQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMAN USE ICHHARMONISEDTRIPARTITEGUIDELINE THECOMMONTECHNICALDOCUMENTFORTHE REGISTRATIONOFPHARMACEUTICALSFORHUMANUSE: ...
ICH HARMONISED TRIPARTITE GUIDELINE ICH协调的三方指南TABLE OF CONTENTS 目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 模块2:通用技术文件综述 2.3 : QUALITY OVERALL SUMMARY (QOS)质量综述(QOS) INTRODUCTION 介绍 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药(名称,制造商) 2.3.S.1 Gener...
Bookmarks should include all tables, figures, publications, other references, and appendices even if these items are not in the table of contents. These bookmarks are essential for the efficient navigation through documents. The use of no more than 4 levels in the hierarchy is recommended, but ...
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of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH (Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Washington DC Meeting, September 11...
M4 CTD (Common Technical Document) Module 1: Administrative Information Module 2: Common Technical Document Summaries 2.1 Common Technical Document Table of Contents (Modules 2-5) 通用技术文档目录(模块2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview ...