Bioequivalence and Bioavailability Forum

Dear both,

❝

• If the study is ongoing, consider serving a reduced amount of food in subsequent period(s) to this particular subject. Any potential food effect should mean out in a cross-over.
• Know your formulation. In a fasted BE study of an IR formulation or an multiparticulate MR formulation it shouldn’t be a big deal. For a monolithic MR formulation with a documented food effect it might matter. Amend the protocol (or at least set up a note to file): Run an outlier test and exclude the subject if significant - supported by statistics and justified by the deviation from the protocol.

The first option can be difficult in practice because it might need a validation of the methods for
1. assessing the actual caloric consumption and composition of the eaten part of the meal.
and
2. matching pt. 1 on the next plate (this involves setting a kind of specification, and FDA needs a justification for specifications. Very hard)