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

作　　者：王筱婧[1] 王东兴[2] 祝倩 林焕冰[4] 李国全 

机构地区：[1]中国药学会 [2]北京军区总医院二六三临床部 [3]解放军95801部队卫生队 [4]广东省食品药品监督管理局审评认证中心 [5]广州市医疗救助服务中心

出　　处：《中国医药科学》2016年第14期221-223,共3页China Medicine And Pharmacy

摘　　要：本文分析了药品技术转让注册过程中质量对比研究的主要内容,对质量标准和样品质量的对比分析进行了探讨;同时结合技术审评中的关注点,对化学药品杂质对比研究、中药复方制剂在质量对比研究中含量测定的专属性、中药材研究的重要性和制剂稳定性对比研究等内容进行了分析说明。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 

分 类 号：R95[医药卫生—药学]