PVLens: Enhancing Pharmacovigilance Through Automated Label Extraction

Fuente: arXiv
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Auteurs principaux: Painter, Jeffery L, Powell, Gregory E, Bate, Andrew
Format: Preprint
Publié: 2025
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author Painter, Jeffery L
Powell, Gregory E
Bate, Andrew
author_facet Painter, Jeffery L
Powell, Gregory E
Bate, Andrew
contents Reliable drug safety reference databases are essential for pharmacovigilance, yet existing resources like SIDER are outdated and static. We introduce PVLens, an automated system that extracts labeled safety information from FDA Structured Product Labels (SPLs) and maps terms to MedDRA. PVLens integrates automation with expert oversight through a web-based review tool. In validation against 97 drug labels, PVLens achieved an F1 score of 0.882, with high recall (0.983) and moderate precision (0.799). By offering a scalable, more accurate and continuously updated alternative to SIDER, PVLens enhances real-time pharamcovigilance with improved accuracy and contemporaneous insights.
format Preprint
id arxiv_https___arxiv_org_abs_2503_20639
institution arXiv
publishDate 2025
record_format arxiv
spellingShingle PVLens: Enhancing Pharmacovigilance Through Automated Label Extraction
Painter, Jeffery L
Powell, Gregory E
Bate, Andrew
Computation and Language
Machine Learning
J.3; H.3.1; D.2.12
Reliable drug safety reference databases are essential for pharmacovigilance, yet existing resources like SIDER are outdated and static. We introduce PVLens, an automated system that extracts labeled safety information from FDA Structured Product Labels (SPLs) and maps terms to MedDRA. PVLens integrates automation with expert oversight through a web-based review tool. In validation against 97 drug labels, PVLens achieved an F1 score of 0.882, with high recall (0.983) and moderate precision (0.799). By offering a scalable, more accurate and continuously updated alternative to SIDER, PVLens enhances real-time pharamcovigilance with improved accuracy and contemporaneous insights.
title PVLens: Enhancing Pharmacovigilance Through Automated Label Extraction
topic Computation and Language
Machine Learning
J.3; H.3.1; D.2.12
url https://arxiv.org/abs/2503.20639