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A Unified Approach to Health Data Exchange: A Report From the US DHHS.
JAMA
January 2025
Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT, Washington, DC.
Importance: Health information technology, such as electronic health records (EHRs), has been widely adopted, yet accessing and exchanging data in the fragmented US health care system remains challenging. To unlock the potential of EHR data to improve patient health, public health, and health care, it is essential to streamline the exchange of health data. As leaders across the US Department of Health and Human Services (DHHS), we describe how DHHS has implemented fundamental building blocks to achieve this vision.
View Article and Find Full Text PDFAdverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study.
Paediatr Drugs
January 2025
Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Background: This study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.
Methods: We searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023.
Factors Associated With FDA-Approved Quit Medication Use Among a Sample of Adult Tobacco Users in a County in Central California.
Am J Health Promot
January 2025
Department of Kinesiology and Public Health, California Polytechnic State University San Luis Obispo, San Luis Obispo, CA, USA.
Purpose: To examine associations between identified factors to accessing Food and Drug Administration-approved quit medication (FDAQM) and use among a sample of tobacco users.
Design: Cross-sectional, online survey.
Setting: County in Central California.
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 PDFA pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database.
Expert Opin Drug Saf
January 2025
Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Background: Faricimab is predominantlyprescribed for conditions such as age-related macular degeneration (AMD),diabetic macular edema (DME), and macular edema related to retinal veinocclusion (RVO-ME). Currently, a notable absence of large-scale, real-worldstudies focusing on the adverse reactions of faricimab exists.
Methods: Thisstudy assesses the side effects of faricimab by analyzing reports of adverseevents (AEs) from the FDA's AEReporting System (FAERS) database.
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