Bioequivalence and Bioavailability Forum

Dear Dr. Dan and GSTATS

❝ if you do a full replicate design you double your Test vs Reference comparisons and by this you have a higher power for the study to show bioequivalence?

I totally agree to you on this!!!
Besides, I recently had an experience with the same molecule for Canada submission. Where we have done a full replicate and BINGO!!!!! The study passed (no CI limit for CANADA required but also very comfortable CI for AUCs with using 30 volunteer per period. Cmax-110%, AUC 110 with CI of 102-119, with ISCV for reference 50% and for test: 40%)

But when the same formulation was dosed for EMEA submission with 30 volunteer/period, we got comfortable results for Cmax (falling in the extended CI range) and higher AUC (upper limit 128 and ISCV of 40% for Cmax and 33% for AUC)

Does this difference in the study is because of number of volunteers in each study or study design and there is no difference in the innovator and test release pattern. (Class II molecule with more than 90% release in 10 min in all the media)

Luv