Niraparib PBPK Model Data for Hepatic Impairment Dose Adjustment

A physiologically based pharmacokinetic (PBPK) model dataset for the drug niraparib, developed to predict optimal dosage in patients with hepatic impairment. The model was built using PK-Sim software and calibrated with an Approximate Bayesian Computation Sequential Monte Carlo approach, based on a systematic literature review of clinical PK data. 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 like LogP and pKa.
• Predicting optimal dose adjustments (e.g., 250 mg for mild impairment) for patients with hepatic impairment categorized by total bilirubin levels.
• Performing sensitivity analysis to identify key determinants of drug exposure, such as pKa and CES1 metabolism specific clearance.
• Validating PBPK model performance against independent clinical pharmacokinetic datasets.

Strengths

• Model validation was performed against independent datasets, confirming performance.
• The dataset includes specific simulation results, such as predicted AUC increases of 33% to 101% across four hepatic impairment groups.
• The model was developed using established software tools (PK-Sim, Open Systems Pharmacology suite) and a systematic literature review following PRISMA guidelines.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count is unknown, which may limit suitability assessment for large-scale analyses.
• The dataset is relatively small at 2.7 MB, potentially limiting the scope of contained data.

Provenance

Source

figshare

Collection Method

Systematic literature review of PubMed and ClinicalTrials.gov, followed by PBPK model development and simulation.

Freshness

Last updated 2026-05-11 05:28:28; freshness should be verified.