Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
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<strong>Pharmacokinetic</strong> <strong>and</strong> <strong>Statistical</strong> <strong>Analysis</strong> <strong>of</strong> <strong>BE</strong> <strong>Data</strong><br />
NCA: othero<br />
PK Metrics<br />
•Single dose<br />
•Metrics describing the shape <strong>of</strong> the pr<strong>of</strong>ile<br />
• C max /AUC<br />
• t 75% = POT-75 (Plateau time, Peak-Occupancy-Time 75:<br />
time interval where C(t) ≥ 75% <strong>of</strong> C max )<br />
• HVD = POT-50 (Half Value Duration, Peak-Occupancy-<br />
Time 50: time interval where C(t) ≥ 50% <strong>of</strong> C max )<br />
• Occupancy time, t ≥ MIC (time interval where C(t) is above<br />
some limiting concentration)<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
9• 50
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