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 Technical Document Summaries 2.1Common Technical Document Table of Conten...
NTA, Volume 2B, CTD-Module 2 Edition July 2003 Module 2.1 Common Technical Document Tableof Contents (Module 2 – 5)通用技术文件目录(模块2-5) Module 2.2 Introduction简介 Module 2.3 Quality Overall Summary质量综述 Module 2.4 Nonclinical Overview非临床概述 Module 2.5 Clinical Overview临床概述 Module...
Table of contents 一、organization 二、M4Q(R1)三、M4S（R2）四、M4E(R1)一、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 ...
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 ...
R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE:人用药物注册通用技术文件 Q UALITY 质量 Q UALITY O VERALL S UMMARY OF M ODULE 2 M ODULE 3:Q UALITY 模块2：质量概要 模块3：质量 Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, ...
Module 2:Common Technical Document Summaries 2.1 CommonTechnical Document Table of Contents (Modules 2-5) 2.2 CTD Introduction 2.3 Quality OverallSummary(QOS) INTRODUCTION 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 2.3.S.1 General ...
4.2StudyReports 4.3LiteratureReferences Module5:ClinicalStudyReports 5.1TableofContentsofModule5 5.2TabularListingofAllClinicalStudies 5.3ClinicalStudyReports 5.4LiteratureReferences (二)该部分文件还附带有GranularityDocument 二、M4Q(R1)质量部分 TABLEOFCONTENTS MODULE2:COMMONTECHNICALDOCUMENTSUMMARIES 2.3:QUALITY...
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...
CTD文件格式总目录.pdf,CTD 文件格式总目录 Table of contents 一、organization 二、M4Q(R1) 三、M4S (R2 )四、M4E(R1) 一、 Organization 组织结构 (一)ORGANISATION OF THE COMMON TECHNICAL DOCUMENT Module 1: Administrative Information and Prescribing Inform
EditedbyAlexmengEmail furenpahrma@gmail.comCTD文件格式总目录Tableofcontents一、organization二、M4QR1三、M4S R 四、M4ER1一、Organization组织结构 一 ORGANISATIONOFTHECOMMONTECHNICALDOCUMENTModule1:AdministrativeInformationandPrescribingInformation1.1T