Physiologically Based Pharmacokinetic Modeling for Mechanistic Analysis of Food Effects: A Case Study with Radotinib.

ABSTRACT:

Purpose

Physiologically based pharmacokinetic (PBPK) modeling has emerged as a promising tool for food effect assessment, yet its utility for poorly soluble and poorly permeable compounds has not been fully established. This study aimed to develop a PBPK model for radotinib, a second-generation tyrosine kinase inhibitor, to predict the food effect.

Methods

The model was verified against plasma concentration-time (Cp-time) data obtained from a clinical trial conducted in healthy volunteers who received an oral dose of 400 mg under fasted and fed conditions. Sensitivity analyses were subsequently performed to identify the absorption-related parameters that influence the prediction of food effect.

Results

All simulated-to-observed ratios for maximum Cp (C_max),

SUBMITTER: Kang M 

PROVIDER: S-EPMC13642456 | biostudies-literature | 2026 Aug

REPOSITORIES: biostudies-literature