Module 3: Quality 3.1Table of Contents of Module 3 3.2Body of Data(数据汇总) 3.2.SDRUG SUBSTANCE (NAME, MANUFACTURER) 3.2.S.1General Information (name, manufacturer) 3.2.S.1.1Nomenclature (name, manufacturer) 3.2.S.1.2Structure (name, manufacturer) 3.2.S.1.3General Properties (name, manufactu...
3.1.TABLE OF CONTENTS OF MODULE 3 模块3目录 3.2. BODY OF DATA主体数据 3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)原料药(名称,制造商) 3.2.S.1 General Information (name, manufacturer)一般信息 3.2.S.1.1 Nomenclature (name, manufacturer) 命名 3.2.S.1.2 Structure (name, manufacturer) 结构...
3.2.S.1.1 Nomenclature (name, manufacturer) 命名 3.2.S.1.2 Structure (name, manufacturer) ...
3.2.S.3 Characterisation(name, manufacturer) 3.2.S.3.1 Elucidation of Structure and other Characteristics (name,manufacturer) 3.2.S.3.2 Impurities (name, manufacturer) 3.2.S.4 Control of DrugSubstance (name, manufacturer) 3.2.S....
CTD格式介绍(中英文对照)
In the above guideline to get a complete idea on the sections under each module you need to focus on the content in the page- 5 M4Q Guideline of ICH–This provides harmonised structure and format for presenting CMC (Chemistry, Manufacturing and Controls) information in a registration dossier...
TABLE OF CONTENTS OF MODULE 3 3.2. BODY OF DATA 3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER) 3.2.S.1 General Information (name, manufacturer) 3.2.S.1.1 Nomenclature (name, manufacturer) 3.2.S.1.2 Structure (name, manufacturer) 3.2.S.1.3 General Properties (name, manufacturer) 3.2.S.2 ...
(name, manufacturer)...5 Structure (name, manufacturer) ...6 General Properties (name, manufacturer)...6 Manufacture (name, manufacturer)...
A Module 1 need not be submitted. If the original Part II contained data on bioequivalence, then this data should be extracted from the Part II and reformatted into the new CTD structure, and annexed in a separate binder as a separate section . Any reformatted documentation should also be ...
CTD T HE C OMMON T ECHNICAL D OCUMENT FOR THE R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE: Q UALITY 人用药品注册的通用技术文件:质量 Q UALITY O VERALL S UMMARY OF M ODULE 2 模块2:质量综述 M ODULE 3 : Q UALITY 模块3:质量 ICH H ARMONISED T RIPARTITE G UIDELINE ICH...