关于生物等效性试验中血药峰浓度等效界值的思考

Consideration about the maximum concentration confidence interval limits in the assessment of bioequivalence

在国内的生物等效性评价中,峰浓度(Cmax)的等效界值尚处在新老标准交替阶段。当Cmax处在新老标准之间,如何进行审评决策,是一个需要认真考虑的问题。本文通过2个药物审评实例,介绍关于该类问题的思考原则和思路,以期为仿制药的研究开发和审评提供参考。

During the assessment of bioequivalence in our country ,the in-terval limits for maximum concentration （ Cmax ） is in an alternating phase.The aim of this paper is to introduce some principles and thoughts of bioequivalence for area under the curve （AUC） and Cmax.Examples of two drugs evaluation were presented here , which might be helpful for the development and review of generics.