细胞毒性筛选在新药研发中的风险分析  

The Risk Research of Cytotoxicity Screening in Research and Development of New Drugs

作　　者：刘亚辉[1] 陈玉文[1] 

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国药业》2015年第17期1-2,共2页China Pharmaceuticals

基　　金：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";项目编号:2013ZX09301305

摘　　要：目的分析细胞毒性筛选在新药研发中存在的风险因素。方法引入风险管理理念,对细胞毒性筛选相关文献进行检索和梳理,提出细胞毒性筛选中存在的风险。结果细胞模型选择存在3个风险因素;评价指标确定存在1个风险因素;单指标检测技术存在7个风险因素,因技术不同风险侧重点也不同;多指标检测技术两种技术各存在2个风险因素。结论对新药研发细胞毒性筛选每一环节的风险进行有效控制,并在此基础上通过联合检测建立体外分层系统毒性筛选平台,是降低新药研发因毒性而研发失败风险的关键。Objective To analyse the risk factors in the research and develoPment of new drugs of cytotoxic screening. Methods The risk management in cytotoxicity screening was introduced,the literature was searched and sorted to bring out the risk in cytotoxicity screening. Results Cell models had three risk factors; the evaluation index had one risk factors;the single index detection techniques had seven risk factors. Conlusion It is the key to reduce the R＆D failures due to toxicity through effective controlling of the risk in every asPect of cytotoxic screening in R＆D;on this basis,establish the tiered system in vitro toxicity screening Platform by joint detection.

关 键 词：细胞毒性 风险管理 评价指标 

分 类 号：R965.1[医药卫生—药理学]