Power and Sample Size Calculations
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Sample size calculations belong to the routine steps in the design of studies for drug development. The importance of the determination of the appropriate sample size for clinical studies is emphasized in the ICH Guidelines: “The number of subjects in a clinical trial should always be large enough to provide a reliable answer to the question addressed.” A simple example may help to understand the basic problem.
KeywordsConfidence Limit Sample Size Calculation Total Sample Size Bioequivalence Study Sequence Group
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