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Best Design of BE Studies (7) - BEBAC • Consultancy Services for ...

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7/7 | Statistical <strong>Design</strong> and Analysis IIII<br />

Dose Proportionality<br />

Two-step procedure<br />

Example (FIM, 6 dose levels, C max )<br />

2000<br />

1500<br />

Dose Proportionality (Cmax)<br />

1000<br />

500<br />

Observed<br />

Predicted<br />

0<br />

0 2 4 6 8 10 12<br />

dose (mg)<br />

in<strong>for</strong>ma<br />

life sciences<br />

Bioequivalence and Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 14 • 19

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