Bioequivalence and Bioavailability Forum

Hi Achievwin,

❝ Welcome to the home of funky and funny pharmacokinetics where "Garbage in Gospel out" is day of life.

❝ 1. allowing long washout periods have seen studies with 4 -5 months washout.

Seen a couple as well.

❝ 2. other choice we can imagine is Two stage adaptive study design and including ANCOA in place of ANOVA...

Slippery grounds – nothing published. You are on your own to demonstrate that the Type I Error is controlled. For the FDA and Health Canada likely simulations are sufficient. For the EMA no way.
I’m a fan of TSDs but if you proceed to the second stage it more than doubles the time of study compared to a fixed sample design. With fast to moderate half lives not an issue. But here?

Furthermore, reference-scaling for HVD(P)s in a TSD is not possible. Some tried, all studies were rejected due to potential inflation of the TIE.