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Integration of Physiologically-Based Pharmacokinetic Modeling into Early Clinical Development: An Investigation of the Pharmacokinetic Nonlinearity

BMS-911543, a promising anticancer agent, exhibited time-dependent and dose-dependent nonlinear pharmacokinetics (PKs) in its first-in-human (FIH) study. Initial physiologically based pharmacokinetic (PBPK) modeling efforts using CYP1A2-mediated clearance kinetics were unsuccessful; however, further...

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Detalles Bibliográficos
Autores principales: Zhou, L, Gan, J, Yoshitsugu, H, Gu, X, Lutz, JD, Masson, E, Humphreys, WG
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452934/
https://www.ncbi.nlm.nih.gov/pubmed/26225254
http://dx.doi.org/10.1002/psp4.35