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 Extrapolation<br />
•AUC 0–∞<br />
•Unweighted log-linear regression <strong>of</strong> ≥3 data points<br />
in the elimination phase<br />
•Don’t rely on s<strong>of</strong>twares’ automatic methods;<br />
visual inspection <strong>of</strong> the fit m<strong>and</strong>atory<br />
•Extrapolation from AUC 0–t (regardless the method)<br />
AUC = AUC + C<br />
Cˆ<br />
∞ t or better AUC<br />
ˆt<br />
∞<br />
AUCt<br />
λ<br />
= +<br />
ˆt<br />
λ<br />
z<br />
z<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
7• 50
Change language