Power and Sample Size Calculations

Jürgen Bock
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Jürgen Bock: F. Hoffmann-La Roche AG

Chapter 11 in Applied Statistics in the Pharmaceutical Industry, 2001, pp 269-297 from Springer

Abstract: Abstract 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.

Keywords: Confidence Limit; Sample Size Calculation; Total Sample Size; Bioequivalence Study; Sequence Group (search for similar items in EconPapers)
Date: 2001
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DOI: 10.1007/978-1-4757-3466-9_11

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