基于CNKI数据库的仿制药一致性评价溶出曲线研究进展

发布时间：2018-04-22 02:19

本文选题：CKNI数据库 + 仿制药　；参考：《中国新药杂志》2017年15期

【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。
[Abstract]:In February 6, 2016, the office of the State Council issued the opinion of the office of the State Council on the evaluation of the consistency of the quality and efficacy of generic pharmaceuticals, and proposed the evaluation of the quality and efficacy of generic drugs in China in May.2016, and CFDA issued the implementation of "the agreement of the general office of the State Council on the evaluation of the consistency of the quality and efficacy of generic drugs." A comparative study of the dissolution curves of solid preparations was carried out by a comparative study of the reference preparation as a contrast. This paper reviewed the correlation of the study on the dissolution curve of the generic drug consistency evaluation from 2013 to 2016 by means of a computer retrieval method of the Chinese CNKI database. The purpose of this study is to provide references for the study of consistency evaluation.

【作者单位】：中国食品药品检定研究院;
【基金】：国家“重大新药创制”科技重大专项资助项目(2015ZX09303001)
【分类号】：R95

【参考文献】