高变异药物生物等效性试验的样本含量估计及PASS软件实现  

Sample Content Estimation of Bioequivalence Test of Highly Variable Drug and PASS Software Implementation

作　　者：黄彦[1] 陈静[1] 

机构地区：[1]重庆市中医院,重庆400021

出　　处：《中国中医急症》2014年第6期1066-1068,共3页Journal of Emergency in Traditional Chinese Medicine

基　　金：重庆市中医院院内培育课题(2012-1-2-17)

摘　　要：高变异药物的生物等效性试验是一个比较复杂的问题,目前CFDA尚未出台其样本含量要求的规定.如果申办者纳入18～24例受试者进入高变异药物的生物等效性试验,将得不出生物等效的结论,此时CFDA会要求申办者通过扩大受试者人数再次进行生物等效性试验.本文采用PASS 2008软件演示了生物等效试验的样本含量估计过程,为申办者计算样本含量的问题提供了参考依据,同时还对高变异药物Cmax的等效性判定标准进行了讨论,这将有助于提高申办者对高变异药物生物等效性试验的认识.The bioequivalence test of highly variable drug was a completely complicated issue.Currently the requirement of sample size was not provided specially by CFDA.If 18～24 subjects were enrolled in the bioequivalence test of highly variable drug,the sponsor would have not draw a correct conclusion of bioequivalence.Then CFDA needed to require another bioequivalence test with increased number of subjects.This study applied the software of PASS 2008 to demonstrate process of sample size estimation,provided a reference for sponsor to solve the complicated problem of sample size estimation,and discussed the equivalent criteria of highly variable drug CE,which would help sponsor to improve the understanding of the bioequivalence test of highly variable drug.

关 键 词：高变异药物 生物等效性 样本含量 PASS软件 

分 类 号：R195[医药卫生—卫生统计学]