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Part of the book series: Springer Series in Pharmaceutical Statistics ((SSPS))

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Abstract

There are complex study designs and analysis methods for which derivation of a closed-form expression for the required sample size is extremely challenging or is not possible at all. In such situations, simulations are a useful and flexible tool for determining the sample size. In this chapter, a general simulation-based approach for a sample size calculation is described and hints for practical implementation are given.

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Correspondence to Meinhard Kieser .

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Kieser, M. (2020). Simulation-Based Sample Size Calculation. In: Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-030-49528-2_16

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