人体生物等效性临床试验风险伦理评估要点初探  

A preliminary study on the ethical risk assessment of human bioequivalence trial

作　　者：钱薇[1] 郑林海 杨迪[3] 叶方琴 杨劲[3] QIAN Wei;ZHENG Linhai;YANG Di;YE Fangqin;YANG Jin(Phase I Clinical Trial Site, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210009, Jiangsu, China;Tianjin Green Pine Pharma. Co. Ltd. Tianjin 300000, China;China Pharma- ceutical University, Nanjing 210009, Jiangsu, China)

机构地区：[1]南京大学医学院附属鼓楼医院Ⅰ期临床试验研究室 [2]天津青松华药医药有限公司,天津300000 [3]中国药科大学

出　　处：《中国临床药理学与治疗学》2017年第9期1077-1080,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：人体生物等效性试验是评价制剂质量的重要指标。由于已有大量药物有效性和安全性的数据积累,因而其伦理风险往往容易被申办方和伦理委员会所忽视。本文列出了几个具体案例,对人体生物等效性试验中伦理风险提出了几个评估要点,包括:药品说明书中的不良反应;种族差异;健康志愿者和适应症患者不良反应差异等,以期为人体等效性试验的伦理风险控制提供有益的参考。Bioequivalence （BE） trail is an im- portant index to evaluate the quality of the preparation. Due to a large number of listed drug efficacy and safety of data accumulation, the ethical risk is often ignored by the sponsor and ethics committee. This article lists specific cases to assess the addition- al ethical risks to health subjects in a human bio- equivalence trial, including examining the drug brochure, racial differences, and the differences of ad-verse reactions between healthy and indications in hope of offering reference for controlling ethical risk in human equivalence trial.

关 键 词：伦理 人体生物等效性试验 阿巴卡韦 来那度胺 单硝酸异山梨酯 氯氮平 伊马替尼 

分 类 号：R969.4[医药卫生—药理学]