Bioequivalence and Bioavailability Forum

Dear Helmut/all,

We are debating on BE strategy for FDA for one of our developmental project.

We have prepared four strengths, i.e. 5 , 10, 20, 40 mg tablets. The PK of innovator is linear over the defined dose range.

in our case, net weight of 5 mg/10 mg tablet is 150 mg, and Net weight of 20/40 mg tablet is 300 mg.

So it will not be possible for us to take biowaiver of lower strengths i.e. 5, 10, 20 based on 40 mg 2*2 cross over study.

so please advise minimum number of studies to be conducted to save time.

Can we do three way cross over study i.e. 40 mg reference*40 mg test* (20*2) mg test?

Based on this can we get waiver for 10 mg strength?

please suggest.

thanks

Purav