Leveraging Omeprazole PBPK/PD Modeling to Inform Drug-Drug Interactions and Specific Recommendations for Pediatric Labeling.

ABSTRACT: Background/Objectives: Omeprazole is widely used for managing gastrointestinal disorders like GERD, ulcers, and H. pylori infections. However, its use in pediatrics presents challenges due to drug interactions (DDIs), metabolic variability, and safety concerns. Omeprazole's pharmacokinetics (PK), primarily influenced by CYP2C19 metabolism, is affected by ontogenetic changes in enzyme expression, complicating dosing in children. Methods: This study aimed to develop and validate a physiologically based pharmacokinetic (PBPK) model for omeprazole and its metabolites to predict age-related variations in metabolism and response. Results: The PBPK model successfully predicted exposure to parent and metabolites in adults and pediatrics, incorporating competitive and me

SUBMITTER: Soliman A 

PROVIDER: S-EPMC11944414 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature