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 />
High variability Modified from Fig. 1<br />
CI <strong>of</strong> ∆<br />
∆<br />
CI <strong>of</strong> ∆<br />
∆<br />
Tothfálusi et al. (2009)<br />
LL UL LL<br />
UL<br />
Counterintuitive<br />
concept <strong>of</strong> <strong>BE</strong>:<br />
Two formulations with<br />
a large difference in<br />
means are declared<br />
bioequivalent if variances<br />
are low, but not<br />
bioequivalent – even<br />
if the difference is<br />
quite small – due to<br />
high variability.<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
34 • 50
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