Bioequivalence and Bioavailability Forum

❝ Could you please explain why do you think that a bioequivalence study is needed? Please note there is no disintegration, dissolution and absorption.

Dear Dr Dan,

Can't we propose a bioequivalence to regulatory authorities for newer FDC even if the route of administration is IV to investigate or prove that when clubbed each individual component would not have any impact on each other's fate in the body?

Correct me if Iam wrong. How to prove the fractional maximal effect (FME) of synergestic fdc combination.

Thanks and kind regards,