Bioequivalence and Bioavailability Forum

Hello everyone.

We are performing the development of a generic drug product of a fixed dose combination. Concering the BE studies, it is nearly impossible to fullfil with the proportionality and less than 5% of the active substance(s) regulations included in the guidance on the investigation of bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **.
In order to cover all the possibilities three BE studies should be performed. But in your expert opinion it is possible to ask for a bracketing approach with the minimum and maximum strenght for every active substance without the proportionality criteria.

Thanks