Bioequivalence and Bioavailability Forum

Dear Mikkabel,

❝ what […] 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?

Well, at least you have a lower risk of a lack of efficacy if the patient takes the product in the fasting state (contrary to the SmPC/package insert) or with a very light meal. The concern could be switchability: if the patient used to take the reference product, or another generic bioequivalent to the reference in the fed and fasting states, and then switches to yours, he will suddenly get higher concentrations which could cause adverse reactions. Particularly if the doctor prescribed a higher dose due to a lack of efficacy.

❝ Do you think that it will be an issue for the assessor that the BE is not demonstrated in both condition in that case?

Who can predict their reactions ?
Impossible to say without any information on the molecule, and even with information I would not try my luck.