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Mapping the future of antimicrobial use data collection in US animal agriculture: insights from FDA-funded pilot studies.
J Am Vet Med Assoc
August 2024
1Center for Veterinary Medicine, US FDA, Rockville, MD.
Antimicrobial use (AMU) contributes to the emergence of antimicrobial resistance, necessitating antimicrobial stewardship actions across all sectors using a One Health approach to preserve antimicrobial effectiveness. This overview delves into 2 FDA-funded projects focused on collecting and analyzing AMU data in major food-producing animal species (cattle, swine, turkeys, and chickens). Initiated in 2016, the projects aimed to establish baseline AMU information and pilot methodologies.
View Article and Find Full Text PDFDevelopment and validation of a rabbit model of non-ventilated pneumonia for preclinical drug development.
Front Cell Infect Microbiol
December 2023
Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.
Background: New drugs targeting antimicrobial resistant pathogens, including , have been challenging to evaluate in clinical trials, particularly for the non-ventilated hospital-acquired pneumonia and ventilator-associated pneumonia indications. Development of new antibacterial drugs is facilitated by preclinical animal models that could predict clinical efficacy in patients with these infections.
Methods: We report here an FDA-funded study to develop a rabbit model of non-ventilated pneumonia with by determining the extent to which the natural history of animal disease reproduced human pathophysiology and conducting validation studies to evaluate whether humanized dosing regimens of two antibiotics, meropenem and tobramycin, can halt or reverse disease progression.
Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study.
Epilepsia
January 2023
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Objective: Lamotrigine is a commonly prescribed antiepileptic drug. U.S.
View Article and Find Full Text PDFEndurance Time During Constant Work Rate Cycle Ergometry in COPD: Development of an Integrated Database From Interventional Studies.
Chronic Obstr Pulm Dis
October 2022
COPD Foundation, Miami, Florida, United States.
Introduction: The COPD Biomarkers Qualification Consortium (CBQC) was formed under COPD Foundation management, with the goal of qualifying biomarkers and clinical outcome assessments through established regulatory processes for chronic obstructive pulmonary disease (COPD). Within CBQC, a working group evaluated opportunities for qualification of an exercise endurance measure. In a recent publication ( 2022; 9[2]:252-265), we described a conceptual framework establishing exercise endurance's direct relationship to an individual with COPD's experience of physical functioning in daily life, and that increase in exercise endurance is a patient-centered, meaningful treatment benefit.
View Article and Find Full Text PDFInnovations in Therapy Development for Rare Diseases Through the Rare Disease Cures Accelerator-Data and Analytics Platform.
Ther Innov Regul Sci
September 2022
Rare Disease Cures Accelerator - Data Analysis Platform (RDCA-DAP), Tucson, USA.
Rare diseases impact the lives of an estimated 350 million people worldwide, and yet about 90% of rare diseases remain without an approved treatment. New technologies have become available, such as gene and oligonucleotide therapies, that offer great promise in treating rare diseases. However, progress toward the development of therapies to treat these diseases is hampered by a limited understanding of the course of each rare disease, how changes in disease progression occur and can be effectively measured over time, and challenges in designing and running clinical trials in diseases where the natural history is poorly characterized.
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