以健康受试者为研究对象的仿制药生物等效性试验不良事件分级标准  

Grading Criteria for Adverse Events in the Trials of Bioequivalence of Generic Drugs with Healthy Subjects

作　　者：肖国民 赵丹丹 徐娴 余国林 肖馨 陈建 XIAO Guomin;ZHAO Dandan;XU Xian;YU Guolin;XIAO Xin;CNEN Jian(Clinical Research Center,Hangzhou Combak Hospital,Hangzhou 310024,China;Clinical Research Center,Zhejiang Xiaoshan Hospital,Hangzhou 311202,China)

机构地区：[1]杭州康柏医院临床研究中心,杭州310024 [2]浙江萧山医院临床研究中心,杭州311202

出　　处：《药学与临床研究》2022年第6期565-568,共4页Pharmaceutical and Clinical Research

摘　　要：药物临床试验不良事件严重程度评估有多种不同的评价标准,但目前尚无专门针对以健康受试者参与为主的仿制药生物等效性试验不良事件分级评价标准。仿制药生物等效性试验有其特殊性,可参考相关最新研究进展的成果,设计适用于以健康受试者为研究对象的仿制药生物等效性试验不良事件分级评价标准,以利于仿制药生物等效性试验安全性数据的评价。There have been various evaluation criteria for the severity of adverse events in drug clinical trials, but there is currently no evaluation criteria for adverse events in bioequivalence trials of generic drugs that mainly involve the participation of healthy subjects. Generic drug bioequivalence trials have their particularities, and the latest research results can be referred to design the adverse event classification evaluation criteria for healthy subjects as the research object, so as to facilitate the evaluation of safety data.

关 键 词：生物等效性试验 不良事件 分级标准 健康受试者 

分 类 号：R969.1[医药卫生—药理学] R951[医药卫生—药学]