创新性药物临床试验的风险管理  

Risk management of the innovative drug clinical trials

作　　者：范华莹[1] 谢振伟[1] 王瓅珏[1] 张华[1] 王豪[1] 

机构地区：[1]北京大学人民医院科研处药物临床试验机构,北京100044

出　　处：《中国临床药理学杂志》2017年第23期2471-2473,共3页The Chinese Journal of Clinical Pharmacology

基　　金：北京国际医药临床研发平台(CRO平台)基金资助项目

摘　　要：近年来,随着我国药品创新能力的提高,新药临床申请和上市申请的数量增多。对于创新性药物而言,由于其人体耐受和药代动力学情况、有效性和安全剂量范围均是未知,需要通过临床试验逐步进行探索确定,风险极高。本文对创新性药物临床试验过程中可能存在的风险因素进行系统分析,并提出应对策略,以提高创新性药物研发的成功率。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 

分 类 号：R97[医药卫生—药品]