Part III - BEBAC ⢠Consultancy Services for Bioequivalence
Part III - BEBAC ⢠Consultancy Services for Bioequivalence
Part III - BEBAC ⢠Consultancy Services for Bioequivalence
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Taking a Biostatistical Approach to Designing a <strong>Bioequivalence</strong>B<br />
Study: Ensuring Success through Effective Planning (3/3)<br />
Potvin et al. (2007)<br />
Advantage<br />
Currently the only validated procedure <strong>for</strong> BE!<br />
Drawbacks<br />
Not validated <strong>for</strong> a correction of effect size (PE)<br />
observed in Stage 1 (must continue with the<br />
one used in sample size planning).<br />
No stop criterion (EMA GL on BE)<br />
Not validated <strong>for</strong> any other design than the<br />
conventional 2×2 crossover (no higher order<br />
cross-overs, no replicate designs).<br />
<strong>Bioequivalence</strong> & Bioavailability Studies | Munich, 252<br />
October 2010<br />
136 • 162
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