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Pharmacokinetic Analysis of BE DataNCA: AUC Extrapolation100plasma profile (semilogarithmic scale)concentration10C tCˆt10 4 8 12 16 20 24timeBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201326 • 68
Pharmacokinetic Analysis of BE DataNCA: otheroPK Metrics•Single dose•C max and t max directly from profile•Metrics describing the shape of the profile• Early exposure (US, CAN): AUC tmax = pAUC truncated atpopulation (CAN: subject’s) t max of the reference• Biphasic MR formulations: pAUCs truncated at a prespecifiedcut-off time point• FDA: Product specific guidances (methylphenidate,zolpidem)• EMA: All productsQuestions & Answers: positions on specific questions addressed to the pharmacokineticsworking partyEMA/618604/2008 Rev. 4 (16 February 2012)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002963.pdfBioequivalence Assessment of Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201327 • 68
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