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...
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...
In addition to taking on the tasks related to the documentation for your dossier, Diapharm also offers support when it comes to the formal requirements imposed on pharmaceutical companies. On request, we will take direct responsibility for your product – for example, by taking over functions in ...
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 ...
A brief description of the manufacturing process (including, for example, reference to starting materials, critical steps, and reprocessing) and the controls that are intended to result in the routine and consistent production of material(s) of appropriate quality;制造过程(如,包括参考起始物料,关键步...
A brief description of the manufacturing process (including, for example, reference to starting materials, critical steps, and reprocessing) and the controls that are intended to result in the routine and consistent production of material(s) of appropriate quality; 制造过程(如,包括参考起始物料,关键...
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 ...
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...
libpython (optional) Used by thepythonplugin. Currently, Python 2.6 and later and Python 3 are supported.http://www.python.org/ libqpid-proton (optional) Used by theamqp1plugin for AMQP 1.0 connections, for example to Qdrouterd.http://qpid.apache.org/ ...
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...