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: otheroPK Metrics•Single dose•Metrics describing the shape <strong>of</strong> the pr<strong>of</strong>ile• C max /AUC• t 75% (Plateau time: interval where C(t) ≥ 75% <strong>of</strong> C max )*• HVD (Half value duration: time interval where C(t) ≥ 50%<strong>of</strong> C max )• Occupancy time, t ≥ MIC (time interval where C(t) is abovesome limiting concentration)* Russia: mandatory for sustained release formulationsBioequivalence Assessment <strong>of</strong> Oral Dosage Forms: Basic Concepts and Practical ApplicationsLeuven, 5–6 June, 201328 • 68
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