摘要
2016年2月6日,国务院办公厅印发《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》,提出我国将开展仿制药质量和疗效一致性评价工作。2016年5月,CFDA发布关于落实《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》有关事项的公告,明确提出一致性评价的研究内容之一是以参比制剂为对照,进行固体制剂溶出曲线的比较研究。本文通过计算机检索中国知网(CNKI)数据库的方式,回顾了2013至2016年仿制药一致性评价工作中与溶出曲线研究相关的文献内容,以期为开展一致性评价研究提供参考。
In the notice of the quality and effect consistency evaluation of generic drugs issued by the State Council on Feb 6,2016,it was put forward that quality and effect consistency evaluation of generic drugs would be carried out in our country. Then in the announcement issued by CFDA in May 2016,it was clearly proposed that the comparison study of dissolution profiles between the test preparation and the reference preparation for oral solid preparations was a part of the consistency evaluation. In this paper,CNKI database was electrically searched,and articles corresponding to the study of dissolution profiles were reviewed. It would provide much assistance on the consistency evaluation in our country.
作者
薛晶
南楠
许鸣镝
李娅萍
XUE Jing NAN Nan XU Ming-di LI Ya-ping(National Institutes for Food and Drug Control, Beijing 100050, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第15期1778-1785,共8页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2015ZX09303001)
关键词
CKNI数据库
仿制药
一致性评价
溶出曲线
CNKI database
generic drugs
consistency evaluation
dissolution profiles
