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A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments.
Clin Pharmacol Ther
January 2025
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Comparisons of maximum drug concentration (C) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs.
View Article and Find Full Text PDFBridging Therapies-Ex Vivo Liver Xenoperfusion and the Role of Machine Perfusion: An Update.
Xenotransplantation
January 2025
Department of Surgery, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Advancements in xenotransplantation intersecting with modern machine perfusion technology offer promising solutions to patients with liver failure providing a valuable bridge to transplantation and extending graft viability beyond current limitations. Patients facing acute or acute chronic liver failure, post-hepatectomy liver failure, or fulminant hepatic failure often require urgent liver transplants which are severely limited by organ shortage, emphasizing the importance of effective bridging approaches. Machine perfusion is now increasingly used to test and use genetically engineered porcine livers in translational studies, addressing the limitations and costs of non-human primate models.
View Article and Find Full Text PDFTrends in utilization of tramadol and other opioids in Denmark 2017-2023: A nationwide drug utilization study.
Br J Clin Pharmacol
January 2025
Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.
The use of tramadol and other opioids for pain management has been accompanied by a multitude of challenges and concerns worldwide. The use of tramadol saw a decline in Denmark during 2017-2019 accompanied by a slight increase in the use of morphine and oxycodone. Using the Danish National Prescription Registry and utilizing data until and including 2023, we aimed to provide updated data on the utilization patterns of tramadol and other opioids in Denmark.
View Article and Find Full Text PDFThe incidence of radiologically verified community-acquired pneumonia requiring hospitalisation in adults living in southern Sweden, 2016-2018: a population-based study.
BMC Infect Dis
January 2025
Clinical Microbiology, Department of Translational Medicine, Faculty of Medicine, Lund University, SE21428, Malmö, Sweden.
Background: Community-acquired pneumonia (CAP) was one of the most common causes of death in the European Union in 2017. Severity and mortality of CAP increase with age and an aging European population will require increased planning for prevention, control, and management of CAP. The purpose of this study was to provide an updated population-based estimate of the incidence of CAP requiring hospitalization in Northern Europe.
View Article and Find Full Text PDFAdherence to multi-target stool DNA testing for colorectal cancer screening in the United States.
Int J Colorectal Dis
January 2025
Exact Sciences Corporation, Madison, WI, USA.
Purpose: Colorectal cancer (CRC) is the second leading cause of cancer mortality in the USA and is highly preventable, with early screening vital for improving outcomes. This study aimed to evaluate adherence rates of multi-target stool DNA (mt-sDNA) testing, following updated guidelines recommending screening starting at age 45.
Methods: This retrospective cohort study used aggregated data from Exact Sciences Laboratories LLC, examining new users (first-time testers) aged 45-85 with commercial, Medicare, or Medicaid insurance who received mt-sDNA test kits (point-of-care) between January 1, 2023, and June 1, 2023.
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