平均生物等效性研究中样本量和把握度估算方法比较  

Comparison of methods for the determination of sample size and power in assessing the equivalence of average bioavailability

作　　者：魏敏吉[1] 贺锐锐 张朴[1] 赵彩芸[1] 吕媛[1] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2017年第22期2291-2294,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的对平均生物等效性研究中样本量和把握度的不同估算方法进行比较。方法列出目前常用的几种估算样本量和把握度方法及其计算原理,通过实例进行样本量估算和把握度计算。结果不同估算方法提供了近似的结果。结论查表和简单计算的方法可以满足大部分估算的要求,而准确的估算需要通过软件计算完成。本文中还提供了较为详细的样本量和把握度数据的列表,供参考。Objective To compare the results of sample size and power calculated with different methods.Methods Several methods used for the determination of sample size and power in the assessing the bioequivalence of average bioavailability were provided,their principles were introduced,and examples were demonstrated.Results Different estimation methods gave similar results.Conclusion Methods by looking up tables and abbreviated calculation are easy and quick to use,and can satisfy majority of the task requirements.Exact calculation of sample size and power can only be accomplished by using the programs provided.Detailed tables with sample size and power at different situations are provided for reference.

关 键 词：平均生物等效性 样本量 把握度 

分 类 号：R97[医药卫生—药品]