ArticleFrontiers in pharmacology2026
Niraparib PBPK modeling to predict optimal dosage in patients with hepatic impairment.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: To develop a physiologically based pharmacokinetic (PBPK) model of niraparib, predictive of optimal dosage in patients with hepatic impairment and of key pharmacological factors of toxicity. Methods: A comprehensive systematic literature review was conducted in PubMed and ClinicalTrials.gov, to gather all sources reporting niraparib PK data, in accordance with PRISMA guidelines. The PBPK model of niraparib was built using the PK-Sim® software (version 12.1). Parameter calibration was performed using an Approximate Bayesian Computation Sequential Monte Carlo (ABC-SMC) approach, which was implemented in R (version 4.0.2). Model development, analysis, validation, and forward simulations were performed using the Open Systems Pharmacology (OSP) suite (version 12.3.1) in R. Results: Five drug-specific parameters (LogP, pKa, intestinal permeability, renal clearance, and carboxylesterase 1 (CES1) metabolism specific clearance (CL Conclusion: The PBPK model reliably reproduced clinical pharmacokinetics, supported dose adjustment strategies for hepatic impairment, and provides a framework for exploring niraparib safety and further dosing in special populations.
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