1、CTD格式申报资料提交要求(药学部分:制剂骨架篇)目录内容CCTD (China)CTD (ICH)3.2.P.1 剂型及产品组成Description and Composition of the Drug Product (name, dosage form)3.2.P.2 产品开发Pharmaceutical Development3.2.P.2.1 处方组成Components of the Drug Product3.2.P.2.1.1 原料药Drug Substance3.2....
制剂骨架篇目录内容cctdchinactdich32p1剂型及产品组成descriptiondrugproductnamedosageform32p2产品开发pharmaceuticaldevelopment32p21处方组成componentsdrugproduct32p211原料药drugsubstance32p212辅料excipients32p22制剂drugproduct32p221处方开发过程formulationdevelopment32p222制剂相关特性overages32p223physicochemicalbiological...
CTD格式申报资料提交要求 (药学部分:制剂——骨架篇) 目录 内容 CCTD (China) CTD (ICH) 3.2.P.1 剂型及产品组成 Description DrugProduct (name, dosage form) 3.2.P.2 产品开发 Pharmaceutical Development 3.2.P.2.1 处方组成 Components DrugProduct 3.2.P.2.1.1 原料药 Drug Substance 3.2.P.2.1.2 辅料...
Pharmaceutical FormulationsRelease ProfilesPrescription DrugsDrug Manufacturinguncompressed solidsPowdersCapsulesReconstitutionProteinsThis guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 CTD format.Sarfaraz K. Niazi...
2.3.P.2.2Pharmaceutical Development 2.3.P.2.2.1 Formulation Development Refer to 3.2.P.2.2.1(Page: ) for the process of formulation development and supporting information. A tabulated summary of the variation and reasons of formulation of different development steps, as well as supporting validation...
2.3.P.2 Pharmaceutical Development (name, dosage form) 2.3.P.3 Manufacture (name, dosage form) 2.3.P.4 Control of Excipients (name, dosage form) 2.3.P.5 Control of Drug Product (name, dosage form) 2.3.P.6 Reference S...
Pharmacovigilance translations are essential for ensuring accurate documentation and resolution of adverse drug reaction cases in global drug development. As the pharmaceutical market expands internationally, timely and precise translations of key pharmacovigilance documents, such as adverse event (AE) reports ...
中国-CTD与ICH-CTD的内容比较 CaelynLiu&PeterHan2013/8/20 .目录 1 .概述_ICH-CTD简介 CTD:CommonTechnicalDocument（通用技术文件）•人用药品注册技术要求国际协调会（ICH）为协调统一各方注册申报资料的格式而制定的通用技术文件，以减少不必要的浪费。2000年11月起草，2002年9月修订发布。（ICHM4Q）•2003...
CTD格式申报资料提交要求 (药学部分:制剂) 目录CTD (ICH) 3.2.P.1 剂型及产品组成 Description and Composition of the Drug Product (name, dosage form) 3.2.P.2 产品开发 Pharmaceutical Development 3.2.P.2.1 处方组成 Components of the Drug Product 3.2.P.2.1.1 原料药 Drug Substance 3.2.P.2.1.2 ...
T HE C OMMON T ECHNICAL D OCUMENT FOR THE R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE:人用药物注册通用技术文件 Q UALITY 质量 Q UALITY O VERALL S UMMARY OF M ODULE 2 M ODULE 3:Q UALITY 模块2：质量概要 模块3：质量 Having reached Step 4 of the ICH Process at the ICH ...