The visual predictive check and real-world data

JournalMethodologyMIDDPharmacometrics

About the publication

Real-world data is a rich source of information for developing pharmacometric models, but it comes with unique challenges. This publication in Clinical Pharmacology & Therapeutics (CPT)  by researchers from InsightRX and Pharmetheus highlights a major issue: traditional VPCs and prediction-corrected VPCs (pcVPCs) can produce misleading results when applied to RWD shaped by adaptive clinical decision-making, such as dosing, sampling, and follow-up.

 

Connected posters

At the PAGE 2026 conference, two posters present novel methodological solutions to accurately diagnose models applied to RWD:

This poster addresses adaptive dosing and sampling by normalizing both observed and simulated data to a fixed reference dataset, such as a fixed BID dosing regimen.

 

This poster describe how corrects simulation biases by matching drawn parameter sets to the observed subject’s empirical Bayes estimates (EBEs), restoring the correlation between parameters and study design.