INTRODUCTION: The FDA Adverse Event Reporting System (FAERS) is a primary data source for identifying unlabeled adverse events (AEs) in a drug or biologic drug product's postmarketing phase. Many AE reports must be reviewed by drug safety experts to ...
Drug-induced liver injury (DILI) presents a significant challenge to drug development and regulatory science. The FDA's Liver Toxicity Knowledge Base (LTKB) evaluated >1000 drugs for their likelihood of causing DILI in humans, of which >700 drugs wer...
Many drugs commonly prescribed during pregnancy lack a fetal safety recommendation - called FDA 'category C' drugs. This study aims to classify these drugs into harmful and safe categories using knowledge gained from chemoinformatics (i.e., pharmacol...
BACKGROUND: Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operationa...
BACKGROUND: Edoxaban is a specific anti-Xa inhibitor that, in comparison to warfarin, has been found to be noninferior for the prevention of stroke or systemic embolism (SSE) and to reduce bleeding significantly in patients with nonvalvular atrial fi...
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...
The western journal of emergency medicine
Jan 1, 2025
INTRODUCTION: Medical device recalls are important to the practice of emergency medicine, as unsafe devices include many ubiquitous items in emergency care, such as vascular access devices, ventilators, infusion pumps, video laryngoscopes, pulse oxim...
Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
Jan 1, 2025
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...