仿制药的杂质研究

来源 :中国医药教育协会仿制药研发分析与变更要求及质量一致性评价研讨会 | 被引量 : 0次 | 上传用户:cntele
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主要内容·概述·杂质控制理念的变迁·仿制药杂质研究的基本思路及方法·杂质研究的案例分析·杂质研究特别关注的问题概述·1、杂质的定义·2、杂质研究的地位·3、仿制药杂质研究的基本要求·4、存在的主要问题杂质的定义·任何影响药物纯度的物质统称为杂质.
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主要内容一.前言二.规格变更依据与技术要求及案例分析三.处方工艺变更依据与技术要求及案例分析四.注册标准变更研究的技术要求及案例分析五.结语一、概述(一)药品变更的定
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