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The following message was posted to: PharmPK
Dear all,
I wish to know how we should predict the bioequivalence of test and
reference products of Class-2 & Class-4 (BCS) before going for a bio-
study.
With Regards
Ashis Kumar Mehta
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The following message was posted to: PharmPK
This is a standard application of GastroPlus, and probably other
software
products as well.
We have demonstrated that GastroPlus virtual bioequivalence trials,
including the effects of population variations in ADME that affect
both test
and reference dosage forms, are a cost-effective way of estimating the
likely distribution of Cmax, Tmax, and AUC for various numbers of
subjects.
Doing such trials is not trivial because of the multidisciplinary
nature of
what is being simulated; however, the information gained can help to
eliminate failed bioequivalence studies, so the savings in time and
cost is
substantial. In addition, such analyses assist in selecting the optimum
number of subjects to demonstrate bioequivalence without overtesting or
underpowering the trial.
Walt Woltosz
Chairman & CEO
Simulations Plus, Inc. (AMEX: SLP)
1220 W. Avenue J
Lancaster, CA 93534-2902
U.S.A.
http://www.simulations-plus.com
Phone: (661) 723-7723
FAX: (661) 723-5524
E-mail: walt.-a-.simulations-plus.com
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