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 />
Potvin et al. (Method B) B<br />
Evaluate <strong>BE</strong> at stage 1 (α 0.0294)<br />
yes<br />
<strong>BE</strong> met?<br />
no<br />
Evaluate power at stage 1 using α-level <strong>of</strong> 0.0294<br />
yes<br />
≥80%?<br />
no<br />
Estimate sample size based on CV intra<br />
,<br />
T/R 0.95, α 0.0294; continue to stage 2<br />
Evaluate <strong>BE</strong> at stage 2 using pooled<br />
data from both stages (α 0.0294)<br />
Pass<br />
Fail<br />
Pass or fail<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
31 • 50
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