Sample size calculation for average bioequivalence studies of generic drugs
MEI He-kun
WANG Jin
CHAI Dong
CAI Yun
WANG Rui
Abstract：As the full conduction of correspondence evaluation of generic drugs in China,average bioequivalence studies as the focus of correspondence evaluation will increase in the near future,so how to get an appropriate sample size for average bioequivalence studies is very important and also difficult.This paper reviewed and summarized the domestic and abroad regulations and guidelines on sample size of bioequivalence studies.The factors that determine sample size,how to calculate sample size,effect of pre-bioequivalence studies and other issues were discussed.Finally,some suggestions were provided on sample size calculation for average bioequivalence studies.
Keywords：correspondence evaluationaverage bioequivalencepharmacokineticssample sizegeneric drugs
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2898-2902 )