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A generic framework for the physiologically‐based pharmacokinetic platform qualification of PK‐Sim and its application to predicting cytochrome P450 3A4–mediated drug–drug interactions

The success of applications of physiologically‐based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a particular intended application purpose. The...

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Detalles Bibliográficos
Autores principales: Frechen, Sebastian, Solodenko, Juri, Wendl, Thomas, Dallmann, André, Ince, Ibrahim, Lehr, Thorsten, Lippert, Jörg, Burghaus, Rolf
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213412/
https://www.ncbi.nlm.nih.gov/pubmed/33946131
http://dx.doi.org/10.1002/psp4.12636