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Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure

The aim of this analysis was to use a physiologically based pharmacokinetic (PBPK) model to predict the impact of changes in dissolution rates on elagolix exposures and define clinically relevant acceptance criteria for dissolution. Varying in vitro dissolution profiles were utilized in a PBPK model...

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Detalles Bibliográficos
Autores principales: Mukherjee, Dwaipayan, Chiney, Manoj S., Shao, Xi, Ju, Tzuchi R., Shebley, Mohamad, Marroum, Patrick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9320978/
https://www.ncbi.nlm.nih.gov/pubmed/35405765
http://dx.doi.org/10.1002/bdd.2315