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On Bioequivalence Metrics | 8268
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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On Bioequivalence Metrics

2nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

Husam Awni Bayoud

Special Issue BABE-2011: Posters: JBB

DOI: 10.4172/0975-0851.1000105

Abstract
I n a typical bioequivalence trial, the determination of the area under the concentration-time profi le, AUC, and the maximum concentration, C max , are the most commonly used measures to assess the bioequivalence of two drug formulations. Th e United States Food and Drug Administration (FDA) (1992) stated that two formulations, test and reference, are bioequivalent if 90% confi dence interval of the ratios Test AUC/Reference AUC and Test C max /Reference C max lie between 0.8 and 1.25 (or between -0.22 and 0.22 aft er the log-transformation). Several authors have noticed that the equality of AUC and C max is necessary but not suffi cient condition for the bioequivalence of two drug formulations (see e.g.; Rescigno and Powers, 1997). Th is is because these pharmacokinetic parameters do not take the profi le shape in consideration. In view of this, several authors in the literature have proposed various bioequivalence metrics to assess the bioequivalence of two formulations by estimating the similarity (or dissimilarity) of two profi les taking the important diff erences between profi les into account. A new bioequivalence metric has been proposed to assess the bioequivalence of test and reference formulations by estimating the percentage of common area under their profi les. Th e performance, in terms of the statistical power, of the previously proposed and the new bioequivalence metrics was evaluated by simulating cross-over bioequivalence trials.
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