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I am presently working on a drug product whose safety and efficacy is
well established. Around 20 ANDA approvals has already been made.
Should I still go for BE studies or is it enough I do dissolution
profile in different medias only?
Thanks
Meera
[Dose, bioavailability, therapeutic window, any previous problems? - db]
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Go a head and do a BE study. so that you can find out whether you drug
product is better or worse than
the ones which have been approved. Dissolution test is not sufficient
to evaluate a dosage form although
it just helps in predicting future problems of Biovailabiliy
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)