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Prioritizing cases from a multi-institutional cohort for a dataset of pathologist annotations.
J Pathol Inform
January 2025
U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Imaging, Diagnostics, and Software Reliability, Silver Spring, MD, United States of America.
Objective: With the increasing energy surrounding the development of artificial intelligence and machine learning (AI/ML) models, the use of the same external validation dataset by various developers allows for a direct comparison of model performance. Through our High Throughput Truthing project, we are creating a validation dataset for AI/ML models trained in the assessment of stromal tumor-infiltrating lymphocytes (sTILs) in triple negative breast cancer (TNBC).
Materials And Methods: We obtained clinical metadata for hematoxylin and eosin-stained glass slides and corresponding scanned whole slide images (WSIs) of TNBC core biopsies from two US academic medical centers.
The Importance of Antibody Titer Determination to the Effective Use of Convalescent Plasma.
Curr Top Microbiol Immunol
December 2024
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Convalescent Plasma (CP) has been used prophylactically and therapeutically over the past century to address a variety of infectious threats. Two tenets of the use of CP were clear from prior experience in the setting of other infectious outbreaks: (1) best results are obtained when CP is given early in the course of the disease, and (2) plasma containing high-titer neutralizing capacity is necessary to achieve optimal results. The magnitude of the COVID-19 pandemic along with the initial lack of effective therapeutic alternatives, combined with the relative safety of the approach of administration of CP, led to the initiation of an expanded access program (EAP) that ultimately provided CP to tens of thousands of individuals.
View Article and Find Full Text PDFReevaluating ADHD and its First-Line Treatment: Insights from DSM-5-TR and Modern Approaches.
Clin Neuropsychiatry
October 2024
Ariel University, University of Cambridge.
Is Attention Deficit Hyperactivity Disorder (ADHD) a "brain disorder"? Should it be managed regularly with stimulant drugs? This article critically examines the evolving biomedical discourse surrounding these questions through a close inspection of the latest edition of the influential psychiatric manual - the DSM-5-TR - as well as additional authoritative sources (e.g., previous DSM editions, consensus statements, FDA communications).
View Article and Find Full Text PDFFDA Approval Summary: Capecitabine Labeling Update under Project Renewal.
Clin Cancer Res
December 2024
Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
On December 14, 2022, the FDA approved revisions to the United States Prescribing Information (USPI) for capecitabine that revised existing indications and dosage regimens, added new indications and their recommended dosage regimens, revised safety information, updated the description of the risk of capecitabine in patients with dihydropyrimidine dehydrogenase deficiency, and edited other sections of the USPI to conform with FDA's current labeling guidance. These supplements were reviewed and approved under Project Renewal, a public health initiative established by the FDA's Oncology Center of Excellence that aims to update the prescribing information of certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This article summarizes the FDA approach that supported revisions to the capecitabine USPI within the context of Project Renewal.
View Article and Find Full Text PDFA Review of the Regulatory Challenges of Personalized Medicine.
Cureus
August 2024
Pharmacy, SRM College of Pharmacy, SRM Institute of Science and Technology (SRMIST), Chennai, IND.
Personalized medicine integrates genomics with clinical and familial histories, revolutionizing healthcare by tailoring treatments to individual patient characteristics. At its core, pharmacogenomics enables the customization of medication prescriptions based on genetic profiles, enhancing drug efficacy and safety. This precision medicine approach addresses disease diagnosis, prevention, and treatment, offering targeted therapies for conditions like autoimmune disorders, rheumatoid arthritis, and neoplastic conditions.
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