Model-Based Decision Making in Early Clinical Development: Minimizing the Impact of a Blood Pressure Adverse Event

We describe how modeling and simulation guided program decisions following a randomized placebo-controlled single-rising oral dose first-in-man trial of compound A where an undesired transient blood pressure (BP) elevation occurred in fasted healthy young adult males. We proposed a lumped-parameter...

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Detalhes bibliográficos
Main Authors: Stroh, Mark, Addy, Carol, Wu, Yunhui, Aubrey Stoch, S., Pourkavoos, Nazaneen, Groff, Michelle, Xu, Yang, Wagner, John, Gottesdiener, Keith, Shadle, Craig, Wang, Hong, Manser, Kimberly, Winchell, Gregory A., Stone, Julie A.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2009
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2664884/
https://ncbi.nlm.nih.gov/pubmed/19199043
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-009-9083-6
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