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 />
<strong>BE</strong> Study Designs<br />
yes<br />
long half life <strong>and</strong>/or<br />
patients in unstable<br />
conditions?<br />
no<br />
no<br />
parallel design<br />
paired design<br />
cross-over design<br />
reliable informations<br />
about CV?<br />
yes<br />
no<br />
yes<br />
multi-arm parallel<br />
higher-order cross-over<br />
>2 formulations?<br />
•No scaling in parallel designs<br />
yes<br />
replicate design<br />
(reference scaling)<br />
fixed sample design<br />
CV >30?<br />
no<br />
2×2 cross-over design<br />
replicate (unscaled)<br />
two-stage design<br />
•Currently no two-stage design if<br />
•Parallel design<br />
•>2 formulations<br />
•Replicate design<br />
•Futility rules (i.e., maximum<br />
sample size) in two-stage designs<br />
problematic<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
12 • 50
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