经典 中英对照 ICH CTD 目录 Module 1, 2, 3, 4, 5 Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical ...
Module 1:Administrative Information and Prescribing Information 1.1 Table of Contents of the SubmissionIncluding Module 1 1.2 Documents Specific to Each Region (forexample, application forms, prescribing information) Module 2:Common Techn...
The ICH Harmonised Tripartite Guideline M4(R3) on Organisation of the Common Technical Document ( 1 ) indicates that the Common Technical Document (CTD) Module 1 should contain administrative documents specific to each region, for example, forms, labeling, etc., and that the format be specified...
张萱20130829 Content 文件金字塔CTD的概念和规则CTD金字塔CTD的应用 举例：ANDA与SFDACTD的对照（ANDA）文件金字塔 提交文件 注册申报 审批 总结文件综合报告 原始数据和记录，基础资料MasterFiles GXP执行 现场检查 文件金字塔 按照文件的生成时期和来源，将药品开发过程中产生的文件归纳成三个...
Module 1: Administrative Information and Prescribing Information Table of Contents of the Submission Including Module 1 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common Technical Document Summaries ...
For Biotech:生物制品:A description of the desired product and product-related substances and a summary of general properties, characteristic features and characterisation data (for example, primary 22、and higher order structure and biological activity), as described in 3.2.S.3.1, should be ...
(forexample,applicationforms, prescribinginformation) Module2:CommonTechnicalDocumentSummaries 2.1CommonTechnicalDocumentTableofContents(Modules2-5) 2.2CTDIntroduction 2.3QualityOverallSummary 2.4NonclinicalOverview 2.5ClinicalOverview 2.6NonclinicalWrittenandTabulatedSummaries Pharmacology Pharmacokinetics Toxicology 2.7...
(for example, application forms, prescribing information) Module 2: Common Technical Document Summaries 2.1 Common Technical Document Table of Contents (Modules 2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary 2.4 Nonclinical Overview 2.5 Clinical Overview 2.6 Nonclinical Written and Tabulated ...
Organization 组织结构 一 ORGANISATION OF THE COMMON TECHNICAL DOCUMENT Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common...
43、properties, characteristic features and characterisation data (for example, primary and higher order structure and biological activity), as described in S3.1,3.2.S.3.1, should be included. 应包括对产品及产品有关物质的描述,及对一般性质、特征和特征数据(例如,初级和高级 结构和生物活性)的小结,如...