Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIISensitivity AnalysisICH E9Section 3.5 Sample Size, paragraph 3 The method by which the sample size is calculatedshould be given in the protocol […]. The basis ofthese estimates should also be given. It is important to investigate the sensitivity of thesample size estimate to a variety of deviations fromthese assumptions and this may be facilitated byproviding a range of sample sizes appropriate for areasonable range of deviations from assumptions. In confirmatory trials, assumptions should normallybe based on published data or on the results ofearlier trials.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201042 • 68
6/6 | Statistical Design and Analysis IIISensitivity AnalysisExamplenQuery Advisor:σ = ln( CV + 1); ln(0.2 + 1) = 0.198042w2 2intrainformalife sciences20% CV:n=2625% CV:power 90% → 78%20% CV, 4 drop outs:power 90% → 87%25% CV, 4 drop outs:power 90% → 69%Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201020% CV, PE 90%:power 90% → 69%43 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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Part II - BEBAC â¢ Consultancy Services for Bioequivalence