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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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Detalhes bibliográficos
Publicado no:CPT Pharmacometrics Syst Pharmacol
Main Authors: Jones, Aksana K., Salem, Ahmed Hamed, Freise, Kevin J.
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6430154/
https://ncbi.nlm.nih.gov/pubmed/30659774
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/psp4.12380
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