Bioequivalence and Bioavailability Forum

Dear HS and Ohlbe,
Many thanks for your prompt responses,

❝ Will formulation A be totally discontinued, or will you develop both a

❝ 1 mg and a 2 mg formulation ?

Yes formulation A will be discontinued. Only a 2 mg tablet is intended for use in Phase III trials.

❝ The decision on your marketing authorisation application will probably

❝ depend on what pivotal information obtained with formulation A you

❝ will submit as part of your application.

We have Clinical pharmacology and dose-ranging studies with formulation A...

-----------
If the BE is not confirmed I believe we would, as highlighted by HS, consider repeating the study or consider a new formulation - depending on the reasons that would explain this failure.

Anne

--
Edit: Standard quotes restored. [HS]