Power determination during drug development: Is optimizing the sample size based on exposure-response analyses underutilized?
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ABSTRACT:
SUBMITTER: Jones AK
PROVIDER: S-EPMC6430154 | biostudies-literature | 2019 Jan
REPOSITORIES: biostudies-literature
Publications
Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure-Response Analyses Underutilized?
Jones Aksana K AK Salem Ahmed Hamed AH Freise Kevin J KJ
CPT: pharmacometrics & systems pharmacology 20190205 3
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 metho ...[more]
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