PharmPK Discussion - BE - truncation for ACE inhibitors for FDA

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On 12 Mar 2007 at 14:25:10, "Veraselitser.at.yahoo.com" (veraselitser.-at-.yahoo.com) sent the message


Dear All,
I would greatly appreciate your opinion on how acceptable would
truncation seem to you regarding bioequivalence studies with ACE
inhibitors for FDA submission? Since the long terminal elimination
half-life is rather reflective of ACE-receptor binding then the true
elimination from the body, and the slow phase only involves a small
fraction of the drug, it would make sense to rather evaluate the
effective elimination phase, for which purpose measurement till 72
hours or so would generally seem sufficient, but these reasons do not
seem to be directly outlined in the FDA guidelines, may I base my
decision to truncate on that, regardless of the ISV?
Any feedback on your experience with FDA on that issue would be of
great value,
Sincere thanks,
Vera.

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