Bioequivalence and Bioavailability Forum

Hi Helmut and all,

Could I sanity-check a downside case
Suppose the Sponsor uses the sequences (S1: C -> D -> A -> B; S2: D -> C -> B -> A) and the Fed part fails to show BE while the fasted part passes.
If the sponsor decides to reformulate, my understanding is that this would require starting over, since a new formulation would invalidate both the fed and fasted data. Is that correct?

Alternatively, if the Sponsor believes the fed miss was a play of chance in a study powered at 80%, he can run another fed study with a larger sample while retaining the original fasted results for submission.
How are reviewers likely to view the initial fed failure alongside a clean fasted outcome? Would submitting both studies make the package look problematic, or is this generally acceptable provided the second fed study succeeds?