ArticleEuropean journal of drug metabolism and pharmacokinetics2022
Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug-Drug Interactions.
Article in European journal of drug metabolism and pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Building Confidence in Physiologically Based Pharmacokinetic Modeling of CYP3A Induction Mediated by Rifampin: An Industry Perspective.Clinical pharmacology and therapeutics · 2025Review
- The calcium-sensing receptor: a comprehensive review on its role in calcium homeostasis and therapeutic implications.American journal of translational research · 2025Review
- Etelcalcetide use During Maintenance Hemodialysis and Incidence of Parathyroidectomy After Kidney Transplantation.Kidney international reports · 2024Article
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Authors and funding
4 authors.
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Abstract
BACKGROUND AND
objectivesIndex substrates and inhibitors to investigate the role of the polymorphic enzyme, cytochrome P450 (CYP) 2D6, in the metabolism of new compounds have been proposed by regulatory agencies. This work describes the development and verification of physiologically-based pharmacokinetic (PBPK) models for the CYP2D6-sensitive substrate, nebivolol and the index CYP2D6 inhibitors, mirabegron and cinacalcet.
methodsPBPK models for nebivolol, mirabegron and cinacalcet were developed using in vitro and clinical data. The performance of the PBPK models was verified by comparing the simulated results against reported human systemic exposure and clinical drug-drug interactions (DDIs) studies.
resultsThe exposure of nebivolol, cinacalcet and mirabegron predicted by the PBPK models was verified against pharmacokinetic data from 13, 3 and 9 clinical studies, respectively. For nebivolol, the predicted mean maximum plasma concentration (C
conclusionsThe developed PBPK models can be used to assess the DDI potential liability of new chemical entities that are substrates or inhibitors of CYP2D6.
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