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
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 ...
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 ...
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 ...
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
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...
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, ...
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
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...
TABLE OF CONTENTS 目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 1 : QUALITY O CTD质量部分中英文指南 来自淘豆网www.taodocs.com转载请标明出处. 文档信息 页数:50 收藏数:0 顶次数:0 上传人:neryka98 文件大小:229 KB 时间:2021-11-22