Therapeutic equivalence? [Design Issues]

posted by Dr_Dan  – Germany, 2011-02-28 15:53 (5096 d 10:41 ago) – Posting: # 6672
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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

Kind regards and have a nice day
Dr_Dan

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