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The following message was posted to: PharmPK
Does anyone have any experience with the design of bioequivalence
studies with drugs known to exhibit time-dependent kinetics? If so, can
you share what experimental design was used and whether it was accepted
by the agency.
As an aside, why do we call the FDA the 'Agency' when it should be 'The
Administration'? I thought the agency was the CIA. Perhaps 'The
Administration' is too ominous.
Peter L. Bonate, PhD
ILEX Oncology, Inc
4545 Horizon Hill Blvd
San Antonio, TX 78229
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