(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 Summaries Pharmacology Pharmacokinetics Toxicology 2.7 Clinical Summary Biopharmaceutic Studies and Associated Analytical Methods Clinical Pharmacology Studies Clinical...
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 Common Technical Document Table of Contents (Modules 2-5) ...
1.2 Documents Specific to Each Region (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(QOS) 质量综述 INTRODUCTION 2.3.S DRUG ...
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 Technical Document Summaries 2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction 2.3 Quality ...
CTD中文版.doc,European Union 欧盟 Administrative Information and Prescribing Information 行政信息和法规信息 Edition May 2008 2008年5月版 Module 1 Table of Content 模块1 内容简介 1.0 Cover Letter 封面1.1 Comprehensive Table of Contents 内容简介 1.2 Applic
1 1.2 Documents Specific to Each Region (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 ...
(Modules2-5) 2.2CTDIntroduction 2.3QualityOverallSummary 2.4NonclinicalOverview 2.5ClinicalOverview 2.6NonclinicalWrittenandTabulatedSummaries Pharmacology Pharmacokinetics Toxicology 2.7ClinicalSummary BiopharmaceuticStudiesandAssociatedAnalyticalMethods ClinicalPharmacologyStudies ClinicalEfficacy ClinicalSafety Literature...
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The reasons for revision were minor changes in the numbering and the headings of the CTD, which have been incorporated in the updated Modules 2, 3, 4 and 5 of the EU CTD NTA. Module 1 was updated in April 2006 taking into account the requirements of the new pharmaceutical legislation. ...
CTD T HE C OMMON T ECHNICAL D OCUMENT FOR THE R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE: Q UALITY 人用药品注册的通用技术文件：质量 Q UALITY O VERALL S UMMARY OF M ODULE 2 模块2：质量综述 M ODULE 3 : Q UALITY 模块3：质量 ICH H ARMONISED T RIPARTITE G UIDELINE ICH...