Pharmacokinetic Analysis of BE Data - BEBAC ⢠Consultancy ...
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>NCA: AUC Extrapolation•AUC 0–∞•Unweighted log-linear regression <strong>of</strong> ≥3 data pointsin the elimination phase•Extrapolation from AUC 0–t (regardless the method)CAUC = AUC + Cˆ∞ t or better AUCtˆt= AUC +∞λˆtλzzBioequivalence Assessment <strong>of</strong> Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201322 • 68
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