Part III - BEBAC • Consultancy Services for Bioequivalence

Taking a Biostatistical Approach to Designing a BioequivalenceB
Study: Ensuring Success through Effective Planning (3/3)
Pilot Studies: Sample Size
Moderate sized pilot studies (sample size
~12–24) lead to more consistent results
(both CV and PE).
If you stated a procedure in your protocol, even
BE may be claimed in the pilot study, and no
further study will be necessary (US-FDA).
If you have some previous hints of high intrasubject
variability (>30%), a pilot study size of
at least 24 subjects is reasonable.
A Sequential Design may also avoid an
unnecessarily large pivotal study.
Bioequivalence & Bioavailability Studies | Munich, 252
October 2010
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