Bioequivalence and Bioavailability Forum

Dear All

Regards!!

We did a full replicate BE study for EU submission a few days back with 40 volunteers.
The %ISCV observed for reference product was found to be 28% (in pilot it was 43%), thus we have to comply with normal 80-125% CI limit criteria, considering the study as a two way study.

Now, if I am considering the study as a normal two way crossover study what option I have
1) take mean of test and reference (e.g. T1+T2/2 and R1+R2/2 and 40 volunteers for each) and run the stats (tried this and study is failing on lower side at 78%)
or
2) I should run the stat for T1+T2 Vs R1+R2 (using total 80 data for each test and reference, tried this and study is passing)

Now which is the right way Statistically, Practically and Regulatory approach wise.

Thanks in advance!!!!

Luv

P.s: I know I am sounding as a moron but need some lesson on this for sure