中国医药科学2016，Vol.6Issue(14)：221-223,3.
药品技术转让质量对比研究的主要内容与关注要点
The focus of the quality research on quality comparison of drug technology transfer
王筱婧 1王东兴 2祝倩 3林焕冰 4李国全5
作者信息
- 1. 中国药学会，北京 100022
- 2. 北京军区总医院二六三临床部，北京 100017
- 3. 解放军95801部队卫生队，北京 100075
- 4. 广东省食品药品监督管理局审评认证中心，广东广州510000
- 5. 广州市医疗救助服务中心，广东广州 510000
- 折叠
摘要
Abstract
This paper analyzed the main content of the quality contrast research in the process of the registration of drug technology transfer and discussed the comparative analysis of quality standard and sample quality. At the same time, combined with the focus of technical review, several important contents were analyzed and explained, which mainly included: comparative study of impurities in chemical drugs, specific properties of the content determination of traditional Chinese medicine compound preparation in the quality contrast study, the importance and the research of Chinese medicinal herbs, comparative study on the stability of preparations and so on.关键词
药品技术转让/质量对比研究/质量标准/药品杂质Key words
Drug technology transfer/Quality comparative study/Quality standard/Drug impurity分类
医药卫生引用本文复制引用
王筱婧,王东兴,祝倩,林焕冰,李国全..药品技术转让质量对比研究的主要内容与关注要点[J].中国医药科学,2016,6(14):221-223,3.
