PBPK Modeling of Varenicline: Relating Variable Pharmacokinetics to Genomics.

Understanding Pharmacokinetic Variability of Pomalidomide: A Physiologically Based Pharmacokinetic Analysis of Disease-Related Physiology, Ethnicity, Hepatic Impairment, Food Effects, Drug Interactions, and Smoking.

BACKGROUND AND OBJECTIVE Understanding interindividual pharmacokinetic variability and potential for drug interactions is of clinical importance for pomalidomide given its long-term use in patients with relapsed and/or refractory multiple myeloma (RRMM). This study aimed to develop a physiologically based pharmacokinet...

Physiologically based pharmacokinetic modeling to predict sumatriptan pharmacokinetics across OCT1 functional groups.

Population pharmacokinetic model as a tool for simulating cyclosporine exposure in children

Therapeutic drug monitoring (TDM) of cyclosporine is indicated due to its variable pharmacokinetics. Demographic, clinical and TDM data are used to develop a population pharmacokinetic (popPK) model. These models identify factors causing variability in drug exposure parameters like maximum (Cmax), minimum concentration...

PBPK Modeling Investigation of IVIVE–Observed Pharmacokinetic Divergence for VU0467319: A Mechanistic Refinement Workflow for Low-Solubility Compounds

Background/Objectives: VU0467319 (VU319), an M1 muscarinic positive allosteric modulator evaluated in Phase 1 studies, exhibits subproportional dose-exposure scaling typical of poorly soluble compounds. This study applies physiologically based pharmacokinetic (PBPK) modeling to investigate the sources of divergence bet...

Population pharmacokinetic modeling of voriconazole based on real-world data for dosing regimen optimization

Objectives This study established a population pharmacokinetic model of voriconazole with the aim of adjusting the dosing regimen of voriconazole. Methods This was a retrospective study in which clinical data from 3,002 patients were collected from their medical records. Based on the inclusion and exclusion criteria, t...

Physiologically Based Pharmacokinetic Modeling to Characterize the Disposition of Topiramate in Children with and without Obesity

Abstract Topiramate (TPM) is used to treat seizures in adults and children ≥2 years. In children, TPM dosing is body weight based. It is unknown whether children with obesity may benefit from an alternative dosing strategy. We developed a novel physiologically based pharmacokinetic (PBPK) model for TPM that accounts fo...