中国药物警戒 ›› 2020, Vol. 17 ›› Issue (9): 549-552.
DOI: 10.19803/j.1672-8629.2020.09.01

• 专家论坛 • 上一篇    下一篇

基于风险管理策略的生物等效性试验设计与实施的考量

薛薇1, 齐文渊1, 刘岳1, 丛端端1, 刘晓慧1, 李鸿艳1, 王娟1, 李可欣1, 胡欣2,*   

  1. 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
  • 收稿日期:2020-07-06 修回日期:2020-08-17 出版日期:2020-09-15 发布日期:2020-08-17
  • 通讯作者: *胡欣,男,博士,主任药师,药学。E-mail:huxinbjyy@126.com
  • 作者简介:胡欣,主任药师,博士生导师,药物临床风险与个体化用药评价北京市重点实验室主任。多年来致力于临床药理、临床药学研究和医疗机构药事管理工作,发表论文100余篇,主编药学专著6部,参加编写书籍10余部。完成新药临床前研究8项,已获新药证书4个;完成新药临床研究40余项。现任国家药典委员会委员、卫健委合理用药专家委员会委员,中国药师协会副会长、中国药学会药物警戒专委会副主委,中国药学会药物信息与评价专委会副主委,中国药品质量监督研究会药品使用监管研究专委会主委。担任《中国药物警戒》等多个国家核心期刊主编或副主编职务。薛薇,女,博士,副主任药师,临床药理学。
  • 基金资助:
    国家科技重大专项基金资助项目(2017ZX09304026)

Design and Implementation of Bioequivalence Tests Based on Risk Management Strategies

XUE Wei1, QI Wenyuan1, LIU Yue1, CONG Duanduan1, LIU Xiaohui1, LI Hongyan1, WANG Juan1, LI Kexin1, HU Xin2,*   

  1. 1Clinical Trial Center, Beijing Hospital/National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China;
    2Department of Pharmacy, Beijing Hospital/National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China
  • Received:2020-07-06 Revised:2020-08-17 Online:2020-09-15 Published:2020-08-17

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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。

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

Abstract: 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.

Key words: risk management, bioequivalence, dabigatran, risk identification, risk assessment, risk decision, risk monitoring and control

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