Bioequivalence and Bioavailability Forum

Dear BJ
I performed several BE studies with imatinib to evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of imatinib after a single oral dose administration under fed conditions, since imatinib should be administered orally with a meal and a glass of water to minimize the risk of gastrointestinal irritations as per label. These were very easy studies since the intra-subject variability of the drug is low and the tolerability is excellent.
Don't worry, it is just an ordinary BE study, no additional safety examinations needed.
Kind regards
Dan