人体生物等效性试验设计的伦理思考

Thinking on ethical principle in bioequivalence studies

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.