摘要
本文以美国FDA植物药开发指南(2015修订稿草案)内容为研究对象;重点分析指南针对临床研究(尤其是后期临床研究)部分的建议和要求,尝试剖析植物药指南的立法思路,分析探讨后期临床研究的重点和难点问题,结合国内企业现实情况提出了系列的可能对策。同时结合FDA上市两个植物药产品案例,分析植物药研发指南法规和成功经验对我国中药新药研发的指导意义和启示,以促进我国中药创新研究进程。
This paper was prepared to analyze and discuss the main content of the Botanical Drug Development Guidance for Industry by United States FDA＇s （the draft version of the 2015）, especially focused on the guidelines for clinical research （mainly in late-stage clinical studies） recommendations and requirements sectiones. The key and difficult issues in the late clinic study were analyzed and discussed, and a series of countermeasures were proposed in this paper. At the same time, combined with the case of approved botanical drug products, analysis of the guidelines for the development of plant drug regulations, the enlightenment were presented in the last part, to guide the research and development of traditional Chinese medicine and the internationalization of Chinese medicine.
出处
《药学学报》
CAS
CSCD
北大核心
2017年第4期505-509,共5页
Acta Pharmaceutica Sinica
关键词
植物药研发工业指南
临床研究
有效性评价
安全性评价
Botanical Drug Development Guidance for Industry
clinical study
efficacy evaluation
safety evaluation
