BACKGROUND: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bi...
To investigate consistency in summaries of product characteristics (SmPCs) of generic antimicrobials, we used natural language processing (NLP) to analyze and compare large amounts of text quantifying consistency between original and generic SmPCs. W...
Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically info...
International journal of environmental research and public health
33477865
Improving global health requires making current and future drugs more effective and affordable. While healthcare systems around the world are faced with increasing costs, branded and generic drug companies are facing the challenge of creating market...
BACKGROUND: Artificial intelligence (AI) and machine learning are transforming the optimization of clinical and patient workflows in healthcare. There is a need for research to specify clinical requirements for AI-enhanced care pathway planning and s...
Passive acoustic monitoring is used widely in ecology, biodiversity, and conservation studies. Data sets collected via acoustic monitoring are often extremely large and built to be processed automatically using artificial intelligence and machine lea...
Studies in health technology and informatics
38269880
With growing use of machine learning (ML)-enabled medical devices by clinicians and consumers safety events involving these systems are emerging. Current analysis of safety events heavily relies on retrospective review by experts, which is time consu...
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 ...
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
39490606
BACKGROUND: Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development. The aim of our study was to develop a model-based approa...