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>Data</strong> Transformation!<br />
Density<br />
Sample Quantiles<br />
0.000 0.005 0.010 0.015 0.020 0.025 0.030 0.035<br />
20 30 40 50 60<br />
MPH, 12 subjects<br />
0 50 100 150<br />
AUC [ng×h/mL]<br />
Shapiro-Wilk p= 0.29667<br />
Normal Q-Q Plot<br />
Density<br />
Sample Quantiles<br />
0.0 0.5 1.0 1.5<br />
3.0 3.2 3.4 3.6 3.8 4.0<br />
MPH, 12 subjects<br />
2.5 3.0 3.5 4.0 4.5 5.0<br />
ln(AUC [ng×h/mL])<br />
Shapiro-Wilk p= 0.85764<br />
Normal Q-Q Plot<br />
<strong>Data</strong> <strong>of</strong> a real<br />
study.<br />
Both tests not<br />
significant<br />
(assumptions<br />
accepted).<br />
Tests not<br />
acceptable<br />
according to<br />
GLs.<br />
Transformation<br />
based on<br />
prior knowledge<br />
(PK)!<br />
-1.5 -1.0 -0.5 0.0 0.5 1.0 1.5<br />
Theoretical Quantiles<br />
-1.5 -1.0 -0.5 0.0 0.5 1.0 1.5<br />
Theoretical Quantiles<br />
1 st MENA Regulatory Conference on Bioequivalence, Biowaivers,<br />
Bioanalysis <strong>and</strong> Dissolution | Amman, 23 – 24 September 2013<br />
16 • 50
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