中国临床药理学杂志2017，Vol.33Issue(23)：2471-2473,3.DOI:10.13699/j.cnki.1001-6821.2017.23.044
创新性药物临床试验的风险管理
Risk management of the innovative drug clinical trials
摘要
Abstract
In recent years,with the improvement of drug innovation capacity in China,the number of investigational new drug application and new drug application increased.For the innovative drugs,because their pharmacodynamics,pharmacokinetics,efficacy and safety are unknown,we need to gradually explore them through clinical trials,during which the risk is extremely high.This article will analyze the risk factors in the innovative drug clinical trials and put forward strategies to improve the rate of success.关键词
创新性药物/临床试验/风险管理Key words
innovative drug/clinical trial/risk management分类
医药卫生引用本文复制引用
范华莹,谢振伟,王瓅珏,张华,王豪..创新性药物临床试验的风险管理[J].中国临床药理学杂志,2017,33(23):2471-2473,3.基金项目
北京国际医药临床研发平台(CRO平台)基金资助项目 （CRO平台）
