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 />
Statistical Assumptions<br />
20 mg XYZ s.d. (405 subjects)<br />
mean 45.3 ± 18.4 (CV 40.7%)<br />
<br />
-20 0 20 40 60 80 100 120<br />
AUC ∞ [ng×h/mL]<br />
<strong>Bioequivalence</strong> & Bioavailability Studies | Munich, 252<br />
October 2010<br />
110 • 162