Bioequivalence and Bioavailability Forum

Thanks Ohlbe for your advice!

I can understand the potential lack of efficacy if the treatment is taken off label by the patient.
Just for my information, what would be the expectation of the regulators if after having performed the study in fasted state, the test product present an higher BA (but still less than in fed condition) than the comparator demonstrating a less food effect from the test product? Do you think that it will be an issue for the assessor that the BE is not demonstrated in both condition in that case?

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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 #5! [Helmut]