人体生物等效性试验设计的伦理思考  

Thinking on ethical principle in bioequivalence studies

作　　者：钱薇[1] 杨劲[2] 陈磊[2] 肖大伟[1] 

机构地区：[1]南京医科大学附属南京第一医院国家药物临床试验机构 [2]中国药科大学药物代谢动力学重点实验室

出　　处：《中国临床药理学与治疗学》2007年第3期349-351,共3页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：药物临床试验首先要符合伦理学原则,伦理学原则要求受试者最大程度受益和尽可能避免伤害。依据此原则,本文对一些特殊药品人体生物等效性试验设计中的伦理问题进行了思考。The clinical trails should be conducted in accordance with the ethical principles that have their origin in the declaration of Helsinki and that are consistent with GCP. A trial should be initiated and continued only if the anticipated benefits justify the risks. According to the principle, this paper gives some thinking on the ethical principle in bioequivalence study of some special drugs.

关 键 词：生物等效性 临床试验 伦理学 

分 类 号：R969[医药卫生—药理学]