Bioequivalence and Bioavailability Forum

❝ what is the proposed solution for such situation?

❝ say the subject did not swallow the IMP (just for fun) and investigators missed that.

❝ There's no way to prove this without direct subject's confession. Game over? The study failed?

»[…] we cannot distinguish between lack of compliance (the subject didn’t take the drug), a product failure, and a subject-by-formulation interaction (the subject belongs to a subpopulation).«