Bioequivalence and Bioavailability Forum

Hi Regaffairs!
I'm a little bit confused, and I think we need some clarification...

❝ We had submitted generic version of X product without BE. The Waiver for the same based on the BCS classification. Off late the review of the dossier has raised question on the BE with notification to submit the data by conducting the same.

You only may get a waiver for an in vivo BE study, if all of the conditions stated in the respective guideline (slightly different from country to country) are fulfilled, i.e., submitting dissolution similarity by an f₂ >50.
Do you mean, you haven't submitted any in vitro data, and are now asked to show them, or your application for a biowaiver was rejected and the regulator now wants to see a biostudy?

Whitout this clarification, it will be difficult to answer your questions.

regards,
Hermann