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 Contents (Modules 2-5) 2.2CTD Introduction 2.3 Quality Overall Su...
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...
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...
5、icals for Human Use:人用药物注册通用技术文件Quality质量Quality Overall Summary of Module 2Module 3 : Quality模块2:质量概要模块3:质量ICH Harmonised Tripartite GuidelineICH三方协调指南Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideli...
MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES 模块2:通用技术文件综述 2.3 : QUALITY OVERALL SUMMARY (QOS)质量综述(QOS) INTRODUCTION 介绍 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药(名称,制造商) 2.3.S.1 General Information (name, manufacturer) 一般信息 2.3.S.2 Manufacture (name, ...
MODULE 2： QUALITY OVERALL SUMMARY 模块2：质量综述 MODULE 3 : QUALITY 模块3：质量 ICH HARMONISED ...
Module 4covers non-clinical and pre-clinical study reports to support safety claims. Module 5covers clinical study reports to support efficacy claims. The electronic form of this marketing authorisation document, known as an eCTD, contains the same information found in a regular CTD. The individual...
30、Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies discussed under the CTD- S module), including cross-referencing to volume and page number in other Modules. 质量概要应包括每部分的充足信息,给质量审核者提供模块 3 的概况。质量概要还...
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) ...
For example:$ python convert.py [FORMAT] -i /data/ctds/one.ctd /data/ctds/two.ctd -o /data/converted-files Will convert /data/ctds/one.ctd into /data/converted-files/one.[EXT] and /data/ctds/two.ctd into /data/converted-files/two.[EXT]. Each converter has a preferred extension...