基于FMECA分析生物等效性临床试验的实施风险因素及其规避方法  

Risk factors and mitigation in clinical trials of drug bioequivalence based on FMECA analysis

作　　者：姚双 丁选胜[1] 刘川 徐纯 YAO Shuang;DING Xuan-sheng;LIU Chuan;XU Chun(China Pharmaceutical University,Nanjing 211198,China;Beijing Clinical Service Center,Beijing 100024,China)

机构地区：[1]中国药科大学,江苏南京211198 [2]北京科林利康医学研究有限公司,北京100024

出　　处：《现代药物与临床》2021年第5期1065-1075,共11页Drugs & Clinic

基　　金：广州市民生科技攻关计划资助研究课题(201803010036)。

摘　　要：通过查阅相关文献并结合笔者实践经验,基于FMECA、问卷调查法,从"试验药物管理、生物检测样本管理、研究者依从性、受试者依从性、病房管理、质量保证"6个层面列出了61个生物等效性试验临床实施阶段的失效模式,完成调查问卷的设计和发放。针对问卷结果运用SPSS 25.0软件计算出了各故障失效模式下对应的风险优先系数值,并按照从大到小的顺序进行风险排序。对处于较高风险以上的失效模式进行原因分析并针对性提出了预防规避措施,有利于促进我国药物生物等效性试验更加科学和规范的开展。Referred to l relevant literatures as well as personal practices, 61 failure modes were listed based on categories of trial products management, sample testing management, investigators compliance, subjects compliance, ward management, and quality assurance in bioequivalent trials, followed by the design and distribution of a questionnaire. When a critical analysis was conducted to have the risk priority number values for all of the corresponding failure modes were calculated with the SPSS 25.0 software, the risks orders were sorted in the highest to the lowest level. Mitigation strategies suggested to deal with these high-risk failure modes would be conducive to improve quality and standardization of drug bioequivalence trials in China.

关 键 词：生物等效性 临床试验 风险因素 故障模式 影响和危害性分析 

分 类 号：R969.1[医药卫生—药理学]