Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
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Sample Size: Sensitivity Analysis• ICH E9• Section 3.5 Sample Size, paragraph 3• The method by which the sample size is calculatedshould be given in the protocol […]. The basis <strong>of</strong> theseestimates should also be given.• It is important to investigate the sensitivity <strong>of</strong> the samplesize estimate to a variety <strong>of</strong> deviations from theseassumptions and this may be facilitated by providing arange <strong>of</strong> sample sizes appropriate for a reasonable range<strong>of</strong> deviations from assumptions.• In confirmatory trials, assumptions should normally bebased on published data or on the results <strong>of</strong> earlier trials.Dissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 53
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