Niraparib PBPK Model for Hepatic Impairment Dose Adjustment

A physiologically based pharmacokinetic (PBPK) model for the drug niraparib, developed to predict optimal dosage in patients with hepatic impairment. The model was built using PK-Sim software and calibrated using an Approximate Bayesian Computation Sequential Monte Carlo approach. It was authored by Anatoly Pokladyuk and last updated on May 11, 2026.

Use Cases

• Simulating niraparib plasma concentration-time profiles based on optimized drug-specific parameters.
• Predicting dose adjustments for patients with hepatic impairment based on total bilirubin levels.
• Conducting sensitivity analysis on pharmacological factors like pKa and specific clearance.
• Validating PBPK model performance against independent clinical datasets.

Strengths

• Model validation was performed against independent datasets, confirming performance.
• The study provides specific simulated AUC increases (33%, 57%, 71%, 101%) for four hepatic impairment groups.
• The work follows PRISMA guidelines for its systematic literature review.

Limitations

• The dataset is a 1.1 MB DOCX file; the underlying data structure and column definitions are unknown.
• Row count is unknown, which may limit suitability assessment for large-scale analysis.
• The description focuses on model methodology; the availability of raw simulation outputs is unclear.

Provenance

Source

figshare

Collection Method

Developed via systematic literature review and computational modeling using PK-Sim and R.

Freshness

Last updated 2026-05-11 05:28:33