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Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

Predicting metabolic drug–drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development, but controversy has reemerged recently about whether in vitro–in vivo extrapolation (IVIVE) using static models can replace dynamic models for some regulatory filings and label recommendations. The aim of this study was to determine if static and dynamic models are equivalent for the quantitative prediction of metabolic DDIs arising from competitive CYP inhibition.

Author(s): Ivan Tiryannik, Aki T. Heikkinen, Iain Gardner, Anthonia Onasanwo, Masoud Jamei, Thomas M. Polasek, Amin Rostami-Hodjegan

Year: 12월 10, 2024

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