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Catoire, H
Retrieved from 14
OPITAC has received a GRAS (Generally Recognized as Safe) notification from the FDA (Food and Drug Administration) in the U.S
An inter-trial comparison between normal subjects and subjects with end-stage renal failure demonstrated that the parent drug Cmax and AUC values were comparable in the 2 groups, whereas the hydroxybupropion and threohydrobupropion metabolites had a 2.3- and 2.8-fold increase, respectively, in AUC for subjects with end-stage renal failure
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