Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?

BACKGROUND AND OBJECTIVE: Mechanistic static and dynamic physiologically based pharmacokinetic models are used in clinical drug development to assess the risk of drug–drug interactions (DDIs). Currently, the use of mechanistic static models is restricted to screening DDI risk for an investigational...

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Detalles Bibliográficos
Autores principales: Gomez-Mantilla, Jose David, Huang, Fenglei, Peters, Sheila Annie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10042977/
https://www.ncbi.nlm.nih.gov/pubmed/36752991
http://dx.doi.org/10.1007/s40262-022-01204-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10042977/
https://www.ncbi.nlm.nih.gov/pubmed/36752991
http://dx.doi.org/10.1007/s40262-022-01204-4

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