Bioequivalence and Bioavailability Forum

Hi Helmut,
Something from my previous experience... Be careful though as it depends on whether one wants to have a food effect or not. In my previous company we strided for no food effect in our NDA 505(b)2 controlled release formulation and we played safe in showing that the fed vs fasted study passed BE by ensuring that the power was sufficient (as in passing the 80-125%). Of course if there was a food effect then though luck but it would be advantageous to have a no food effect product (Unless product needs to be given with food to enhance BA or reduce AEs).

Thanks
John

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]