Bioequivalence and Bioavailability Forum

Dear rgamage
sorry, there has been a misunderstanding. You have to show similarity within your formulation. If you demonstrated BE between your generic 100mg vs reference product 100mg, then you have to show that your generic 100mg vs generic 50mg f2 passes and your generic 100mg vs generic 25mg f2 passes in order to waive the BE study.
If smaller tablets show dissolution rates which are faster and fail to pass f2 in most conditions, you should evaluate if your method is not overdiscriminating.
I hope this helps.
Kind regards
Dan