Bioequivalence and Bioavailability Forum

Dear Dan & all

❝ IVIVC = in-vitro in-vivo correlation, i.e. you need to have more than one set of clinical data.

Yep. I agree with [msg]John’s #2[/msg]:

❝    IVIVC is a great tool in formulation development, optimization.

IMHO many (most?) generic companies are still lacking experience with IVIVC. Formulators forget that at the end of the day the formulation should match the reference in vivo. They fiddle around with dissolution media for quality control instead of trying to find discriminatory and/or biorelevant media. I have seen too many fruitless pilot studies of candidate formulations – which were developed by “gut feeling”… But it is not too late! The best way to set up a successful IVIVC is in vivo first and then find a discriminatory dissolution method. Hence, with all the available in vivo data the first step is already done!
Quoting Jean-Michel Cardot:

“If Earl Grey with sugar and a sip of milk turns out to be discriminatory – use it!”