Sample Content Estimation of Bioequivalence Test of Highly Variable Drug and PASS Software Implementation
Ya Huang · Journal of Emergency in Traditional Chinese Medicine · 2014
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 Cmax,which would help sponsor to improve the understanding of the bioequivalence test of highly variable drug.