顾博士GenericDrug_CMCRequirement_2012Nov1答辩.pptVIP

A Discussion from Chemistry, Manufacturing, and Controls Perspective;Definition of a Generic Drug仿制药的定义;*;Generic Injections 注射剂仿制药;Generic Oral Solid Dosage Forms 仿制口服固体制剂;*;Completeness of ANDA;3.2.S Drug Substance;CTD-Format;3.2.S Drug Substance ;Active Pharmaceutical Ingredient(Drug Substance) 原料药;Understand How to Apply QbD concept in API development ;3.2.S.1 General Information 原料药的概况 ;3.2.S.2 Manufacturer 原料药生产商 ;3.2.S.3 Characterization of DS 原料药结构解析 ;Impurity Information 杂质信息(Example);3.2.S.4 Control of DS  原料药质量控制;DS Specification 原料药质量标准(Example) ;DS Test Resu