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Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure‐Response Analyses Underutilized?

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 determi...

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Detalles Bibliográficos
Autores principales: Jones, Aksana K., Salem, Ahmed Hamed, Freise, Kevin J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430154/
https://www.ncbi.nlm.nih.gov/pubmed/30659774
http://dx.doi.org/10.1002/psp4.12380