Bioequivalence and Bioavailability Forum

Dear John & Helmut
Maybe I worked for the wrong generic companies but I never faced a problem which needed to be solved by IVIVC....
However, IMHO the general practice for a generic is as follows: You develop a formulation which is stable and shows similar dissolution profiles compared to the reference product. Then you conduct a BE study which passes and that´s it. (Lucky shot?) You have your generic product and you can sell it. No post pilot bio-study formulation. In my opinion IVIVC is extra money no one wants to spent in the generic industry. Yes, you are right this would increase the knowledge about your product, but who cares? As long as you have a bioequivalent product and do not want to change anything there is no need for IVIVC. IMHO IVIVC is a nice intellectual game. For the originator industry this is of course different since the reference product is not established.
I know my attitudy will raise your protest...
Kind regards
Dr_Dan