{"title":"Establishment of a visualization platform for ADR query and analysis: an example of severe skin adverse reactions caused by sulfonylureas.","authors":"Hui-Min Yu, Ya-Min Huang, Jian Xiao, Lu Zhang, Hang-Xing Huang, Ling Huang, Jing-Yang Li, Xin-Qiong Huang","doi":"10.1007/s00228-025-03842-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to develop a visualization platform for querying and analysing data from the FDA Adverse Event Reporting System (FAERS) to support the efficient collection, review, and analysis of adverse drug reactions (ADRs) for pharmacovigilance.</p><p><strong>Methods: </strong>Data acquisition, cleaning, and integration processes were conducted to prepare FAERS data for analysis. The platform was designed with key functionalities, including multi-condition query, drug and ADR query, primary ID query, and interactive visualizations. Usability was demonstrated through a case study investigating the association between sulfonylureas and serious skin ADRs. Additionally, the platform's accuracy was validated by comparing its outputs with manually retrieved and visualized data using a separate test case involving aspirin and tremor.</p><p><strong>Results: </strong>The platform provides an interface with advanced query and visualization features, enabling users to efficiently retrieve, analyse, and visualize ADR data. Usability was illustrated by dynamically exploring FAERS data to identify safety signals for sulfonylureas and serious skin ADRs. The validation process confirmed the platform's reliability by showing consistent results with manually processed data, demonstrating its potential to streamline PV workflows and improve data interpretation.</p><p><strong>Conclusion: </strong>The visualization platform represents a novel and practical tool for pharmacovigilance research. By offering intuitive data query and analysis capabilities, the platform supports drug safety monitoring and promotes the development of pharmacovigilance practices.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1055-1067"},"PeriodicalIF":2.7000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00228-025-03842-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/29 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: This study aimed to develop a visualization platform for querying and analysing data from the FDA Adverse Event Reporting System (FAERS) to support the efficient collection, review, and analysis of adverse drug reactions (ADRs) for pharmacovigilance.
Methods: Data acquisition, cleaning, and integration processes were conducted to prepare FAERS data for analysis. The platform was designed with key functionalities, including multi-condition query, drug and ADR query, primary ID query, and interactive visualizations. Usability was demonstrated through a case study investigating the association between sulfonylureas and serious skin ADRs. Additionally, the platform's accuracy was validated by comparing its outputs with manually retrieved and visualized data using a separate test case involving aspirin and tremor.
Results: The platform provides an interface with advanced query and visualization features, enabling users to efficiently retrieve, analyse, and visualize ADR data. Usability was illustrated by dynamically exploring FAERS data to identify safety signals for sulfonylureas and serious skin ADRs. The validation process confirmed the platform's reliability by showing consistent results with manually processed data, demonstrating its potential to streamline PV workflows and improve data interpretation.
Conclusion: The visualization platform represents a novel and practical tool for pharmacovigilance research. By offering intuitive data query and analysis capabilities, the platform supports drug safety monitoring and promotes the development of pharmacovigilance practices.
期刊介绍：
The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed.
Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor.
Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves
-a compound that is interesting and new in some basic or fundamental way, or
-methods that are original in some basic sense, or
-a highly unexpected outcome, or
-conclusions that are scientifically novel in some basic or fundamental sense.
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