基于风险管理策略的生物等效性试验设计与实施的考量  

Design and Implementation of Bioequivalence Tests Based on Risk Management Strategies

作　　者：薛薇[1] 齐文渊[1] 刘岳[1] 丛端端 刘晓慧 李鸿艳[1] 王娟 李可欣[1] 胡欣[2] XUE Wei;QI Wenyuan;LIU Yue;CONG Duanduan;LIU Xiaohui;LI Hongyan;WANG Juan;LI Kexin;HU Xin(Clinical Trial Center,Beijing Hospital/National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Pharmacy,Beijing Hospital/National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院,国家老年医学中心,中国医学科学院老年医学研究院临床试验研究中心,北京100730 [2]北京医院,国家老年医学中心,中国医学科学院老年医学研究院药学部,北京100730

出　　处：《中国药物警戒》2020年第9期549-552,558,共5页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项基金资助项目(2017ZX09304026)。

摘　　要：目的阐释研究者基于风险管理策略,在生物等效性研究的设计及实施中进行的考量,为防范目前我国大规模BE研究中潜在安全性风险提供参考。方法基于风险管理的一般流程,通过达比加群BE研究中出血风险的管控案例,从风险识别、风险评估、风险决策、风险监控等层面考量研究设计与实施。结果将出血风险识别为研究的重要风险,风险级别根据出血部位及量进行评估,试验实施中严格执行风险决策,严密监控残留风险。该研究未发生出血及相关不良事件,所有受试者安全出组。结论该研究风险管理达到预期目标,印证了基于风险管理的BE研究设计与实施的科学性与有效性。Objective To explain the considerations of investigators in the design and implementation of bioequivalence(BE)studies based on risk management strategies,so as to provide references for preventing potential security risks in large-scale BE studies in China.Methods Based on the general process of risk management and a dabigatran BE study,the research design and implementation were considered from the aspects of risk identification,risk assessment,risk decision-making,risk monitoring.Results The risk of bleeding was identified as an important risk in the study,and the risk level was evaluated according to the location and amount of bleeding.No bleeding and related adverse events occurred in the study,and all subjects were safely excluded from the study.Conclusion The risk management of this study has achieved the expected goals,which confirms the scientificity and effectiveness of the design and implementation based on risk management.

关 键 词：风险管理 生物等效性 达比加群 风险识别 风险评估 风险决策 风险监控 

分 类 号：R954[医药卫生—药学]