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Dear readers,
I have two formulations, test and referance. When the formulation is
administered with food, the Cmax is increasing and the t max is getting
shorter, but the extent of absorption remaining the same. What kind of
clinical studies need to be conducted to prove the bioequivalence between
test and reference formulations.
Does the fed and fasted state studies have to be conducted together or only
fed state clinical studies would be adequate to prove the bioequivalence.
Since the food is the only effect changing the BA parameters???
Thanks for your input on the matter
Sibel D. Ucpinar
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The most similar case would be itraconazole, very lipid soluble and
the absorption increase with fatty food and not much or rather
decrease with non-fat food. In that case the drug should be studied
in fed and fast state to prove bioequivalence. There is FDA
regulation concerning the kinds of food for the fed study(fatty
food). When the absorption increased, Tmax may get be shorter. If the
difference of absorption is not that big, because of the kinds of the
food, there may not be a significant difference in total AUC but may
in some parameters.
Hope this would be helpful.
Kwon K.I.
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)