A Multifactorial Algorithm to Automate Screening of Drug-Induced Liver Injury Cases in Clinical and Post-Marketing Settings

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</div> <div class="row mt-3"> <div class="col-sm-3"> <div class="card"> <div class="card-body"><strong>Commenced</strong> in January 2007</div> </div> </div> <div class="col-sm-3"> <div class="card"> <div class="card-body"><strong>Frequency:</strong> Monthly</div> </div> </div> <div class="col-sm-3"> <div class="card"> <div class="card-body"><strong>Edition:</strong> International</div> </div> </div> <div class="col-sm-3"> <div class="card"> <div class="card-body"><strong>Paper Count:</strong> 88663</div> </div> </div> </div> <div class="card publication-listing mt-3 mb-3"> <h5 class="card-header" style="font-size:.9rem">A Multifactorial Algorithm to Automate Screening of Drug-Induced Liver Injury Cases in Clinical and Post-Marketing Settings</h5> <div class="card-body"> <p class="card-text"><strong>Authors:</strong> <a href="https://publications.waset.org/abstracts/search?q=Osman%20Turkoglu">Osman Turkoglu</a>, <a href="https://publications.waset.org/abstracts/search?q=Alvin%20Estilo"> Alvin Estilo</a>, <a href="https://publications.waset.org/abstracts/search?q=Ritu%20Gupta"> Ritu Gupta</a>, <a href="https://publications.waset.org/abstracts/search?q=Liliam%20Pineda-Salgado"> Liliam Pineda-Salgado</a>, <a href="https://publications.waset.org/abstracts/search?q=Rajesh%20Pandey"> Rajesh Pandey</a> </p> <p class="card-text"><strong>Abstract:</strong></p> Background: Hepatotoxicity can be linked to a variety of clinical symptoms and histopathological signs, posing a great challenge in the surveillance of suspected drug-induced liver injury (DILI) cases in the safety database. Additionally, the majority of such cases are rare, idiosyncratic, highly unpredictable, and tend to demonstrate unique individual susceptibility; these qualities, in turn, lend to a pharmacovigilance monitoring process that is often tedious and time-consuming. Objective: Develop a multifactorial algorithm to assist pharmacovigilance physicians in identifying high-risk hepatotoxicity cases associated with DILI from the sponsor鈥檚 safety database (Argus). Methods: Multifactorial selection criteria were established using Structured Query Language (SQL) and the TIBCO Spotfire庐 visualization tool, via a combination of word fragments, wildcard strings, and mathematical constructs, based on Hy鈥檚 law criteria and pattern of injury (R-value). These criteria excluded non-eligible cases from monthly line listings mined from the Argus safety database. The capabilities and limitations of these criteria were verified by comparing a manual review of all monthly cases with system-generated monthly listings over six months. Results: On an average, over a period of six months, the algorithm accurately identified 92% of DILI cases meeting established criteria. The automated process easily compared liver enzyme elevations with baseline values, reducing the screening time to under 15 minutes as opposed to multiple hours exhausted using a cognitively laborious, manual process. Limitations of the algorithm include its inability to identify cases associated with non-standard laboratory tests, naming conventions, and/or incomplete/incorrectly entered laboratory values. Conclusions: The newly developed multifactorial algorithm proved to be extremely useful in detecting potential DILI cases, while heightening the vigilance of the drug safety department. Additionally, the application of this algorithm may be useful in identifying a potential signal for DILI in drugs not yet known to cause liver injury (e.g., drugs in the initial phases of development). This algorithm also carries the potential for universal application, due to its product-agnostic data and keyword mining features. Plans for the tool include improving it into a fully automated application, thereby completely eliminating a manual screening process. <iframe src="https://publications.waset.org/abstracts/89410.pdf" style="width:100%; height:400px;" frameborder="0"></iframe> <p class="card-text"><strong>Keywords:</strong> <a href="https://publications.waset.org/abstracts/search?q=automation" title="automation">automation</a>, <a href="https://publications.waset.org/abstracts/search?q=drug-induced%20liver%20injury" title=" drug-induced liver injury"> drug-induced liver injury</a>, <a href="https://publications.waset.org/abstracts/search?q=pharmacovigilance" title=" pharmacovigilance"> pharmacovigilance</a>, <a href="https://publications.waset.org/abstracts/search?q=post-marketing" title=" post-marketing"> post-marketing</a> </p> <a href="https://publications.waset.org/abstracts/89410/a-multifactorial-algorithm-to-automate-screening-of-drug-induced-liver-injury-cases-in-clinical-and-post-marketing-settings" class="btn btn-primary btn-sm">Procedia</a> <a href="https://publications.waset.org/abstracts/89410.pdf" target="_blank" class="btn btn-primary btn-sm">PDF</a> <span class="bg-info text-light px-1 py-1 float-right rounded"> Downloads <span class="badge badge-light">157</span> </span> </div> </div> </div> </main> <footer> <div id="infolinks" class="pt-3 pb-2"> <div class="container"> <div style="background-color:#f5f5f5;" class="p-3"> <div class="row"> <div class="col-md-2"> <ul class="list-unstyled"> About <li><a href="https://waset.org/page/support">About Us</a></li> <li><a href="https://waset.org/page/support#legal-information">Legal</a></li> <li><a target="_blank" rel="nofollow" href="https://publications.waset.org/static/files/WASET-16th-foundational-anniversary.pdf">WASET celebrates its 16th foundational 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A Multifactorial Algorithm to Automate Screening of Drug-Induced Liver Injury Cases in Clinical and Post-Marketing Settings