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Pharmacokinetic Analysis of BE Data - BEBAC • Consultancy ...

Pharmacokinetic Analysis of BE Data - BEBAC • Consultancy ...

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<strong>Pharmacokinetic</strong> <strong>Analysis</strong> <strong>of</strong> <strong>BE</strong> <strong>Data</strong>Sampling at Cmax•Quote from the literature:C max was observed within two to five hoursafter oral administration…•Elimination is drug specific,•but what about absorption?•Formulation specific!•Dependent on the sampling schedule (in a strictsense study-specific)Bioequivalence Assessment <strong>of</strong> Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201346 • 68

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