PharmPK Discussion - Truncated AUCs

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On 20 May 2003 at 16:49:50, "Dunnington, Shelly" (DunningtonShelly.at.PRAIntl.COM) sent the message


Does anyone have any experience they can share regarding the FDA's
preferences for reporting a truncated AUC (0-tmax or 0-2*tmax) in an
NDA (not an ANDA) for an immediate release, short-acting, acute
indication drug which is being compared to a similar formulation that
is currently being marketed. The FDA comments, as related to me
second-hand, were not clear as to whether this parameter was needed for
bioequivalence or for supportive documentation.

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