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Mutaz Jaber
Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, USA
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Research Article
Models, Optimal Sampling and Bioequivalence-A New Paradigm Case Study for a Drug with Complex Absorption Modified Release Methylphenidate
Author(s): Andre J. Jackson*, Mutaz Jaber, Henry C. Foehl and Inder Chaudhary
Purpose: The purpose of the investigation was to compare the performance of ordinary sampling versus optimal sampling in Bioequivalence (BE) studies for an Extended-Release (ER) oral Methylphenidate (MP) tablet with complex absorption Concerta®. Methods: For approval of generic versions of Concerta®, the FDA recommends a replicated crossover BE study design be used to define subject-by-formulation interaction variance and inclusion of pAUC (partial Area-Underthe-Curve metrics), in addition to standard metrics. Comparisons between ordinary and optimal sampling for the metrics was determined by the calculation of 90% Confidence Intervals (CIs) for selected Test/Reference (T/R) ratios (0.8, 0.9,0.95,1.0,1.10, and 1.25) for K0fast (zero-order fast absorption rate constant) and KAslow (first-order slow absorption ra.. View more»