Key clinical considerations for demonstrating the utility of preclinical models to predict clinical drug-induced torsades de pointes

Utility of a physiologically–based pharm

Utility of a physiologically–based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug–drug–disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

✍ Joseph A. Grillo; Ping Zhao; Julie Bullock; Brian P. Booth; Min Lu; Kathy Robie- 📂 Article 📅 2012 🏛 John Wiley and Sons 🌐 English ⚖ 535 KB

Background: Rivaroxaban is an oral Factor Xa inhibitor. The primary objective of this communication was to quantitatively predict changes in rivaroxaban exposure when individuals with varying degrees of renal impairment are co-administered with another drug that is both a P-gp and a moderate CYP3A4