ICH指导原则 (cde.org.cn) M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human UseM4(R4):人用药物注册通用技术文档的组织(中文版:征求意见稿)M4 …
CTD Common Technical Document CTD的英文全称为Common Technical Document，是人用药品注册技术要求国际协调会（ICH）撰写的通用技术文件。起草这个文件的目的是为了规范各个地区的注册申请文件，提高注册机构的评审效率，节约有限的药品审评时间和资源，加强同申请人之间的沟通与交流，同时更有助于实现各注册机构之间注册...
Drug information journal : DIJ / Drug Information Associationde Cremiers F. ICH M4/the common technical document (CTD): comparison of clinical documents and summaries assessment practices in the United States, Europe and Japan. Drug Inf Jnl 1999; 33 :601–614.s...
com Common Technical Document (CTD) Harmonised format of docu-mentation to be submitted for marketing applications in the three ICH-regions; Module 1 contains the administrative and prescribing information documents specific to each regional regulatory agency; Module 2 contains the quality overall summary...
A one-page introduction of the pharmaceutical 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; ...
通用 技術文件 (Common Technical Document, 以下簡稱為 CTD) 為一通用 格式, 將品質、 安全、有效之資料所須呈現之方式作系統性之編排。 其主要包含五個文件模組: 模組一 (Module 1)包含行政及處方資訊, 而且必須含括各區域或國家特有之文件內... 文档格式:PDF | 页数:5 | 浏览次数:88 | 上传日期:2012...
网络释义 1. 通用技术文件 术语集 ... ... (Case Report Form) → 病例报告表 (Common Technical Document)通用技术文件(Data Management) … www.epscn-hq.cn|基于12个网页 2. 共同技术文件 制剂如何通过TGA现场检查或认证 ... •共同技术文件(Common Technical Document) •严重缺陷 Critical deficiency...
USFDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.1 美国FDA 模块1 eCTD v4.0 实施指南 v1.1 2017.2.20 This document only includes the specification information for eCTD v4.0 Modules 2 – 5 submission contents which are shared across all regions. The eCTD v4....
列印 System email template message in SystemAdministration(EmailTemplateMessageSystemEntity) 發行項 2022/02/22 4 位參與者 意見反應 本文內容 Traits Attributes Latest version of the JSON entity definition is available onGitHub. Traits Traits for this entity are li...
4 7.1.6.2 Laser Frequency Deviation 5 7.1.6.3 Laser Temperature 6 7.2 Command Data Block (CDB) Message Communication 7 7.2.1 Feature Overview 8 7.2.2 CDB Technical Basics 9 7.2.3 CDB Message Sending and Reply Receiving (Host) 10 7.2.4 CDB Message Receiving and Reply Sending (Module) 11 ...