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

• Main Authors: David Damoiseaux (Author), Wenlong Li (Author), Alejandra Martínez-Chávez (Author), Jos H. Beijnen (Author), Alfred H. Schinkel (Author), Alwin D. R. Huitema (Author), Thomas P. C. Dorlo (Author)
• Format: Book
• Published: MDPI AG, 2022-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...