Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIEUEMA BE Guideline (2010)The number of subjects to be included in the studyshould be based on anappropriateCookbook?sample size calculation.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201010 • 68
6/6 | Statistical Design and Analysis IIIHintsLiterature search for CV%Preferably other BE studies (the bigger, the better!)PK interaction studies (Cave: mainly in steadystate! Generally lower CV than after SD)Food studies (CV higher/lower than fasted!)If CV intra is not given (quite often), a little algebrahelps. All you need is the 90% geometricconfidence interval and the sample size. Point estimate (PE) from the CIPE = CL ⋅CLlohiinformalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201011 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence