Bioequivalence and Bioavailability Forum

Dear Daniel!

Just to keep terminology high: it's not possible to demonstrate bioequivalence between MR and IR, because this would imply no differences both in extend and rate (only possible for IR v.s. IR, or MR v.s. MR).

At least for the EU, even if your MR OAD formulation is mimicking an IR formulation given BID, and you succeed with almost superimposable curves, you will have to a lot of stuff to show (food effect [dose dumping!], eventually steady state, and almost for sure a clinical study as well...; for a nice story see this post).

For an overview of work to be done see the European Note for Guidance (especially Section 4 and Appendix 1).

P.S. I agree with Gagandeep's post (we should design sampling schedules to get the highest possible amount of information from the profiles of both formulations).