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...
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...
CTDopts/example.py/ Jump to 262 lines (224 sloc)11.8 KB RawBlame # or for easier access of certain commonly used module methods importdatetime importpprint importCTDopts.CTDopts# once you installed it, it's just CTDopts fromCTDopts.CTDoptsimportCTDModel,args_from_file,parse_cl_directives,fl...
The QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 2.3.S.1 General Information (name, manufacturer) Information from 3.2.S.1 should be included. 2.3.S.2 Manufacture...
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...
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...
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 ...
1.2 Documents Specific to Each Region (forexample, application forms, prescribing information) Module 2:Common Technical Document Summaries 2.1 CommonTechnical Document Table of Contents (Modules 2-5)2.2 CTD Introduction2.3 Quality OverallSummary(QOS)INTRODUCTION2.3.S DRUG SUBSTANCE ...
Sample scripts to generate graphs reside incontrib/in the source package or somewhere near/usr/share/doc/collectdin most distributions. Please be aware that those script are meant as a starting point for your own experiments. Some of them require theRRDsPerl module. (librrds-perlon Debian) ...
2、 REGISTRATIONEGISTRATION OFOF P PHARMACEUTICALSHARMACEUTICALS FORFOR HHUMANUMAN UUSESE: : 人用药物注册通用技术文件人用药物注册通用技术文件 Q QUALITYUALITY 质量质量 Q QUALITYUALITY O OVERALLVERALL S SUMMARYUMMARY OFOF MMODULEODULE 2 2 MMODULEODULE 3 3 : : Q QUALITYUALITY 模块模块 2 2:质量...