Overview and Introduction - BEBAC ⢠Consultancy Services for ...
Overview and Introduction - BEBAC ⢠Consultancy Services for ...
Overview and Introduction - BEBAC ⢠Consultancy Services for ...
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1/6 | <strong>Overview</strong> & <strong>Introduction</strong>Main Topicsin<strong>for</strong>malife sciencesNCA / PK (PD)Sampling scheduleMetrics (AUC, C max ; AUEC, Ae max ,…)Design, methods, evaluationSample sizeEstimation from previous <strong>and</strong>/or pilot studies,literatureHighly variable drugsBiostatisticsModels & assumptionsProtocol, evaluation, reportBioequivalence <strong>and</strong> Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 2010 8 • 10
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