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Title of Journal: Pharm Res

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Abbravation: Pharmaceutical Research

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Springer US

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DOI

10.1002/ar.1092200402

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ISSN

1573-904X

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Use of Partial AUC PAUC to Evaluate Bioequivalen

Authors: Jeanne Fourie Zirkelbach Andre J Jackson Yaning Wang Donald J Schuirmann
Publish Date: 2012/09/25
Volume: 30, Issue: 1, Pages: 191-202
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Abstract

Methylphenidate modifiedrelease products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder ADHD Standard bioequivalence BE criteria cannot be applied to these products The performance of partial area under the drug concentrationtime curve PAUC Cmax and AUCINF to assess BE were independently evaluated for two productsA twostage analysis was performed on plasma data for two methylphenidate modifiedrelease products Product 1 and 2 Simulations using the fitted parameters determined how changes in fast absorption rate constant K0Fast and fraction available F1 affected curve shape and BE determination using Cmax AUCINF and PAUCThe sensitivity of the mean PAUCtest/PAUCreference ratios to changes in K0Fasttest are product dependent Product 1 mean PAUCtest/PAUCreference ratios for PAUC04h are more responsive to both decreases and increases in K0Fasttest than Product 2 Product 2 showed a greater response in the mean PAUCtest/PAUCreference ratio for PAUC04h when the K0Fasttest is decreased and less response as the value is increased

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