山东农业科学Issue(12)：125-128,4.DOI:10.14083/j.issn.1001-4942.2015.12.030
中药新药研发中的风险与控制
Risks and Their Control in New Traditional Chinese Medicine Research and Development
摘要
Abstract
Using literature survey method,the risks coexisting with the new traditional Chinese medicine research and development (R&D)were analyzed,and some control approaches were put forward in this pa-per.The results showed that five special risks were found during the research and development of new Tradi-tional Chinese medicines,including assessment before set -up project,formulation determination,raw materi-al control,design of manufacture technology and finished product quality control.In conclusion,the risk anal-ysis and control should be conducted on the key links,even throughout the whole process of new traditional Chinese medicine research and development;the risks should be avoided,timely and effectively responded or shifted as soon as possible,and the high risk rate should be reduced scientifically and reasonably in the process of new drug research and development.关键词
中药/新药研发/风险控制Key words
Traditional Chinese medicine/New drug research and development/Risk control分类
化学化工引用本文复制引用
纪晓琳,陈玉文,逯茂洋..中药新药研发中的风险与控制[J].山东农业科学,2015,(12):125-128,4.基金项目
科技部“十二五”重大新药创制国家科技重大专项“辽宁省国家重大新药创制综合平台---基于信息管理的新药研发风险控制技术” （）
