CTD Module 4 relates to the Non-Clinical Study Reports in the CTD File that will be reviewed and submitted for approval in the Pharmaceutical industry. Having a program like MasterControl Solutions to help keep the CTD organized can help your company.
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...
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 Technical Document Summaries 2.1 CommonTechnical Document Table of ...
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 Information 1.1 Table of Contents of the Submission Including Module 1 1.2...
EditedbyAlexmengEmail:furenpahrma@gmail CTD文件格式总目录 Tableofcontents 一、organization 二、M4Q(R1) 三、M4S(R2) 四、M4E(R1) 一、Organization组织结构 (一)ORGANISATIONOFTHECOMMONTECHNICALDOCUMENT Module1:AdministrativeInformationandPrescribingInformation 1.1TableofContentsoftheSubmissionIncludingModule1 1.2...
CTD格式介绍(中英文对照)
NTA, Volume 2B, CTD-Module 2 Edition July 2003 Module 2.1 Common Technical Document Table of 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...
description should be provided; Module 3 provides the chemical-pharmaceutical and biological information for both chemically active substances and biological medicinal products; Module 4 and 5 contain the nonclinical and clinical study reports, respectively; each Module is preceded by a table of contents...
3.1 Module 3 Table of Contents模块三内容 3.2 Body of Data具体数据 3.3 Key Literature References关键参考文献 Module 4: Nonclinical Study Reports非临床研究报告 4.1 Module 4 Table of Contents模块四内容 4.2 Study Reports研究报告 4.3 Literature References参考文献 Module 5: Clinical Study Reports临床研究报...
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 TABLE OF CONTENTS 目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 1 2.3 : QUALITY OVERALL SUMMARY (QOS) 1 INTRODUCTION 1 2.3.S DRUG SUBSTANCE...