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Development and validation of a UHPLC-MS/MS method for the quantitative analysis of trans-ISRIB in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci
January 2025
Department of Chemistry, Cleveland State University, Cleveland, OH 44115, USA. Electronic address:
The integrated stress response (ISR) is a cellular defense mechanism activated under stress conditions. When the ISR is activated, it slows the production of proteins, the building blocks that cells need to function. Trans-integrated stress response inhibitor (trans-ISRIB) is a compound that can reverse the effects of ISR activation, showing promise for treating neurodegenerative diseases.
View Article and Find Full Text PDFCharacterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.
BMJ Med
April 2024
Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Article Synopsis
- The study assessed how the National Comprehensive Cancer Network (NCCN) guidelines reflect updates on oncology drugs that received accelerated approval from the FDA between 2009 and 2018.
- It found that while all indications were included in NCCN guidelines, only a small percentage of them accurately reported the accelerated approval status, with most postapproval trials confirming drug benefits.
- Additionally, NCCN guidelines often updated their recommendations based on FDA decisions about drug approval statuses, aligning closely with both positive and negative outcomes from confirmatory trials.
Colchicine and plaque: A focus on atherosclerosis imaging.
Prog Cardiovasc Dis
June 2024
Division of Cardiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, 1124 West Carson Street, Torrance, CA 90502, USA.
Article Synopsis
- Colchicine is an anti-inflammatory drug traditionally used for autoimmune diseases but is now recognized for its role in managing cardiovascular diseases (CVD) and coronary artery disease (CAD), especially after FDA approval in 2023.
- The medication works by targeting various anti-inflammatory pathways, leading to reduced cardiovascular events and modifications in atherosclerotic plaque.
- This review paper aims to clarify colchicine's new role as a plaque modifier, consolidating existing research and clinical findings to assist healthcare professionals in effectively utilizing it alongside other CVD treatment strategies.
Out of balance: conflicts of interest persist in food chemicals determined to be generally recognized as safe.
Environ Health
September 2023
Independent Consultant, Frederick, MD, USA.
Manufacturers of chemicals added to food are responsible for determining that the use of their products is safe. There are two major legal definitions of chemicals in food: (1) food additives which includes ingredients and chemicals indirectly entering food from packaging and processing equipment, and (2) generally recognized as safe (GRAS) substances mostly used as ingredients. The law requires food additives to undergo approval by the U.
View Article and Find Full Text PDFEvaluating adverse effects of environmental agents in food: a brief critique of the US FDA's criteria.
Environ Health
April 2023
Departments of Pediatrics, Environmental Medicine, and Population Health, New York University School of Medicine, New York, NY, USA.
Background: In the US, the Food and Drug Administration (US FDA) is charged with protecting the safety of food from both pathogens and chemicals used in food production and food packaging. To protect the public in a transparent manner, the FDA needs to have an operational definition of what it considers to be an "adverse effect" so that it can take action against harmful agents. The FDA has recently published two statements where, for the first time, it defines the characteristics of an adverse effect that it uses to interpret toxicity studies.
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