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Updated: Jan 30, 2026

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Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure-Response Analyses
Aksana K Jones1, Ahmed Hamed Salem1,2, Kevin J Freise1
1Abbvie, Inc., North Chicago, Illinois, USA.
Abstract:
The use of model-based drug development (MBDD) has been demonstrated to improve the efficiency of clinical trial design. However, MBDD complexity can limit its use, particularly early in clinical development. In this tutorial, a simple and generalizable exposure-response analysis approach to determine the power for dose-ranging studies is presented and described. We identified situations in which higher power and sample size reduction is achieved by utilizing the exposure-response powering methodology compared with conventional power calculations.
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