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

• Hauptverfasser: David Damoiseaux (Verfasst von), Wenlong Li (Verfasst von), Alejandra Martínez-Chávez (Verfasst von), Jos H. Beijnen (Verfasst von), Alfred H. Schinkel (Verfasst von), Alwin D. R. Huitema (Verfasst von), Thomas P. C. Dorlo (Verfasst von)
• Format: Buch
• Veröffentlicht: MDPI AG, 2022-07-01T00:00:00Z.
• Schlagworte: article
• Online-Zugang: 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...