Module 2 Common Technical Document Summaries
通用技术文件总结
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
Module 2.6 Nonclinical Summary 非临床摘要
Module 2.7 Clinical Summary 临床总结
Module 2.1 Common Technical Document Table of Contents (Modules 2 – 5) 通用技术文件目录（模块2-5）
Module 2: Common Technical Document Summaries 通用技术文件摘要
2.1 CTD Table of Contents (Module 2 – 5) CTD文件目录
2.2 CTD Introduction CTD简介
2.3 Quality Overall Summary 质量摘要
2.4 Nonclinical Overview 非临床概述
2.5 Clinical Overview 临床概述
2.6 Nonclinical Written and Tabulated Summary 书面临床摘要和列表的摘要
Pharmacology 药理学
Pharmacokinetics 药物代谢学梦见升职
Toxicology 毒理学
2.7 Clinical Summary 临床摘要
Biopharmaceutics and Associated Analytical Methods 生物制药学和相关检测方法
Clinical Pharmacology Studies 临床药理学
Clinical Efficacy 临床效用
Clinical Safety 临床安全性
Synops of Individual Studies 个体性状研究
Module 3: Quality 质量
3.1 Module 3 Table of Contents 模块三内容
3.2 Body of Data 具体数据
3.3 Key Literature References 关键参考文献
Module 4: Nonclinical Study Reports 非临床研究报告
4.1 Module 4 Table of Contents 模块四内容
4.2 Study Reports 研究报告
4.3 Literature References 参考文献高校教师个人总结
Module 5: Clinical Study Reports 临床研究报告
5.1 Module 5 Table of Contents 模块五内容
5.2 Tabular Listing of All Clinical Studies 所有临床研究数据列表
5.3 Clinical Study Reports 临床研究报告
5.4 Literature References 参考文献
Module 2.2贺一纯 Introduction 简介
The general introduction to the medicinal product should include its pharmacological class, mode of action and the propod clinical u. In general the introduction should not exceed one page.
关于药品的简要介绍包括：药理级别，服用方法，建议中临床效果，建议此部分不超过一页
Module 2.3 Quality Overall Summary 质量综述
The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. The QOS should not include information, data or justification that 飞行员张超was not already included in Module 3 or in other parts of the CTD.
质量综述（QOS）是根据第三模块的数据做的总结。质量综述不应该包括第三模块没有准备好的数据和CTD中其余的数据。
The QOS should include sufficient information from each ction to provide the Quality reviewer with an overview of Module 3. The QOS should also emphasi critical key para
meters of the product and provide, for instance, justification in cas where guidelines were not followed.
质量综述应该包括含每部分详细的信息，以方便第三模块的质量模块回顾。此部分应该强调产品关键的工艺参数。
The QOS should include a discussion of key issues that integrates information from
ctions in the Quality Module and supporting information from other Modules (e.g.
qualification of impurities via toxicological studies discusd under the CTD-S module),
including cross-referencing to volume and page number in other Modules.
质量综述应该包括关键问题的讨论，融合了质量模块部分的相关信心，以及其它模块相关信息（举例：CTD-S模块下，杂质质量与毒理研究的对比研究）
This QOS normally should not exceed 40 pages of text, excluding tables and figures. For biotech products and products manufactured using more complex process, the docum
ent could be 健身房练胸longer but normally should not exceed 80 pages of text (excluding tables and figures). The italicid text below indicates where tables, figures, or other items can be imported directly from Module 3.
野性的呼唤读后感英文
质量综述正常情况下不可以超过40页（不包括表格和数据）。对于生物产品可能使用更复杂的过程，，文件可以稍长一些但不要超过80页（不包括表格和数据）。
数据，图表和其他的相关项目可以写在第三模块中
INTRODUCTION 简介
The introduction should include proprietary name, non-proprietary name, European
Pharmacopoeia name or common name of the drug substance, company name, dosage form(s), strength(s), route of administration according to the current version of the Standard Terms of the European Pharmacopoeia and propod indication(s)
简介部分应当包括专利药品的名称，非专利药品的名称，欧盟药典名称或者是原料药的通
用名臣，公司名称，剂型，药效，行政信息，上述信息必须根据是欧盟药典现行条款的标准版本。
向领导请假
2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药（名称，生产商）
2.3.S.1 General Information (name, manufacturer) 简明信息（名称，生产商）
Information from 3.2.S.1 should be included. 相见3.2S1的相关部分
2.3.S.2 Manufacture (name, manufacturer) 生产信息（名称，生产商）
Information from 3.2.S.2 should be included: 3.2S.2的相关信息
红花逍遥胶囊• Information on the manufacturer; 关于制造商的相关信息
