摘要
针对医药行业内对中药复方新药申请临床研究立题依据认识不足的情况,从临床技术评价角度,对近年来中药复方新药研发的现状和路径进行了回顾分析,并对临床评价中存在的相关问题,从组方合理性、人用经验和临床研究方案角度探讨分析,提出了中药复方新药临床技术评价存在的困难与对策,以期共同提高中药新药临床研究的水平。
In view of the industry lacking of sufficient analyses on the bases of project establishment about the new drugs of traditional Chinese medicine（TCM） during their applying for the clinical research, from the perspective of clinical evaluation, this paper reviewed and analyzed the present situation and development paths of new drugs of TCM in recent years. Through the analyses of the rationality of formulations, human use experiences and clinical studies, the paper puts forward the countermeasures to solve these difficulties during the technical evaluation of new drugs of TCM in order to improve the new drugs＇ clinical research.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2017年第5期844-847,共4页
China Journal of Chinese Materia Medica
基金
国家中医药管理局中医药行业专项(201207009)
关键词
立题依据
中药复方
临床审评
project basis
traditional Chinese medicine prescription
clinical evaluation
