Physiologically Based Pharmacokinetic Modeling of Tofacitinib: Predicting Drug Exposure and Optimizing Dosage in Special Populations and Drug-Drug Interaction Scenarios.

ABSTRACT: Background: Tofacitinib is mainly used in the adult population for immune-mediated inflammatory diseases. There is little information available on the pharmacokinetics of tofacitinib in pediatric patients, populations with hepatic impairment and renal impairment, and patients with drug-drug interactions (DDIs). This study aimed to develop a physiologically based pharmacokinetic (PBPK) model to predict the pharmacokinetics of tofacitinib in the populations mentioned above. Methods: We developed the PBPK models in PK-Sim^® and evaluated the models with observed clinical PK data. The Monte Carlo algorithm was used for parameter identification. Results: The adult PBPK model accurately simulated the pharmacokinetic profiles of all administration scenarios. The geo

SUBMITTER: Cao Z 

PROVIDER: S-EPMC11945186 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature