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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2023
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| Materias: | |
| 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 |