Therapeutic equivalence? [Design Issues]
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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
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- Therapeutic equivalence? bjkim97 2011-02-23 11:06
- Therapeutic equivalence?Dr_Dan 2011-02-28 14:53
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- Therapeutic equivalence?Dr_Dan 2011-02-28 14:53
- Therapeutic equivalence? Mauricio Sampaio 2024-06-17 02:21
- Therapeutic equivalence? Dr_Dan 2011-02-08 14:40
- Therapeutic equivalence raghu 2011-02-09 10:07
- Therapeutic equivalence? d_labes 2011-02-08 10:37