CTD制剂部分学习之——骨架篇(共23页).doc

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.P.2.1.2 辅料Excipients3.2.P.2.2 制剂Drug Product3.2.P.2.2.1 处方开发过程Formulation Development3.2.P.2.2.2 制剂相关特性Overages3.2.P.2.2.3Physicochemical and Biological Properties