Journal of the American Pharmacists Association : JAPhA
Nov 6, 2024
BACKGROUND: The Food and Drug Administration mandates patient labeling materials like the Medication Guide (MG) and Instructions for Use (IFU) to support appropriate medication use. However, challenges such as low health literacy and difficulties nav...
IMPORTANCE: During the COVID-19 pandemic, the effective distribution of limited treatments became a crucial policy goal. Yet, limited research exists using electronic health record data and machine learning techniques, such as policy learning trees (...
IMPORTANCE: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA...
INTRODUCTION: The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse ev...
Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse events (AEs) after submission to the FDA Adverse Event Reporting System as part of it...
INTRODUCTION: Current drug-drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to false-positive disproportionality signals in spontaneous reporting system (SRS) databases.
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes ...
Artificial intelligence (AI) techniques are currently harnessed to revolutionize the domain of medical imaging. This review investigates 3 major AI-driven approaches for contrast agent management: new frontiers in contrast agent dose reduction, the c...
Artificial intelligence (AI) and machine learning (ML) represent significant advancements in computing, building on technologies that humanity has developed over millions of years-from the abacus to quantum computers. These tools have reached a pivot...
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