Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Pharmacokinetic and Statistical Analysis of BE Data - BEBAC ...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>Pharmacokinetic</strong> <strong>and</strong> <strong>Statistical</strong> <strong>Analysis</strong> <strong>of</strong> <strong>BE</strong> <strong>Data</strong><br />
NCA: AUC<br />
•Recommended: lin-up/log-down trapezoidal rule<br />
•Hybrid <strong>of</strong> linear <strong>and</strong> log-linear<br />
•Sections with increasing or equal concentrations<br />
(C i+1 ≥ C i ) calculated by linear trapezoidal rule<br />
•Sections with decreasing concentrations<br />
(C i+1 < C i ) calculated by log-linear trapezoidal rule<br />
•Avoids bias in both absorption <strong>and</strong> distribution/<br />
elimination phases<br />
•Suitable for IV <strong>and</strong> EV<br />
•Suitable for multiphasic pr<strong>of</strong>iles<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
5• 50
Change language