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Prediction of CYP‐mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

Physiologically‐based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending, or indeed requesting, more rigorous demonstration of the predicti...

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Detalles Bibliográficos
Autores principales: Kilford, Peter J., Chen, Kuan‐Fu, Crewe, Kim, Gardner, Iain, Hatley, Oliver, Ke, Alice Ban, Neuhoff, Sibylle, Zhang, Mian, Rowland Yeo, Karen
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/PMC9286715/
https://www.ncbi.nlm.nih.gov/pubmed/35445542
http://dx.doi.org/10.1002/psp4.12794