Predictiveness of the Human-CYP3A4-Transgenic Mouse Model (Cyp3aXAV) for Human Drug Exposure of CYP3A4-Metabolized Drugs

Predictiveness of the Human-CYP3A4-Transgenic Mouse Model (Cyp3aXAV) for Human Drug Exposure of CYP3A4-Metabolized Drugs

The extrapolation of drug exposure between species remains a challenging step in drug development, contributing to the low success rate of drug approval. As a consequence, extrapolation of toxicology from animal models to humans to evaluate safe, first-in-human (FIH) doses requires high safety margi...

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Bibliographic Details
Main Authors: David Damoiseaux, Wenlong Li, Alejandra Martínez-Chávez, Jos H. Beijnen, Alfred H. Schinkel, Alwin D. R. Huitema, Thomas P. C. Dorlo
Format: Article
Language:English
Published: MDPI AG 2022-07-01
Series:Pharmaceuticals
Subjects:
population pharmacokinetics
extrapolation
first-in-human dose
Human-CYP3A4-transgenic mouse
CYP3A4-metabolized small-molecule drugs
Online Access:https://www.mdpi.com/1424-8247/15/7/860

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