Bioequivalence and Bioavailability Forum

Dear Luv

❝ There are many published literature available about impact of excipient on bioavailability (see this), permeability, GIT residence time and so on.

This is my problem. You will find an endless number of papers describing an impact of an excipient on a special drug substance. What I need is a rationale that at least for drugs considered for a biowaiver the difference in quantitative (and qualitative) composition would not affect the in-vivo performance as long as in vitro dissolution tests show similarity between the test product and the reference. Otherwise you could nearly kill every biowaiver approach, because you do not know the exact quantitative composition of the reference and how to decide which difference would become significant and relevant?
Kind regards
Dan