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From Endoscopic Inspection to Gene-Expression: A Thorough Assessment of the Duodenal Mucosa After Resurfacing-A Prospective Study.
Dig Dis Sci
January 2025
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Location AMC, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands.
Aims: Duodenal Mucosal Resurfacing (DMR) is an endoscopic ablation technique aimed at improving glycemia in patients with type 2 diabetes mellitus (T2DM). Although the exact underlying mechanism is still unclear, it is postulated that the DMR-induced improvements are the result of changes in the duodenal mucosa. For this reason, we assessed macroscopic and microscopic changes in the duodenal mucosa induced by DMR + GLP-1RA.
View Article and Find Full Text PDFUse of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFBioactivities and industrial standardization status of : A comprehensive review.
Heliyon
October 2024
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
(GL) is a potent source of bioactive compounds with diverse nutritional and pharmacological benefits. Its popularity as a dietary supplement, herbal remedy, and wellness product is steadily on the rise. Furthermore, the standardized advancement of the GL industry has facilitated reliable sourcing of raw materials and quality control measures, enhancing its utilization and endorsement in the realms of nutritional science and pharmaceutical research.
View Article and Find Full Text PDFEvaluating Cardiovascular Benefits of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) in Type 2 Diabetes Mellitus: A Systematic Review.
Cureus
August 2024
Surgical Oncology, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA.
Cardiovascular risks and complications remain elevated in patients with type 2 diabetes even after appropriate control of contributing factors like glycemic control, hypertension, and lipid profile. More efficient methods are needed to address this issue in type 2 diabetics. Newer drugs like glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown a cardioprotective effect in addition to glycemic control.
View Article and Find Full Text PDFManufacturing, quality control, and GLP-grade preclinical study of nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles.
Stem Cell Res Ther
April 2024
Cellular Biomedicine Group (Shanghai), Co. Ltd., 85 Faladi Road, Building 3, Zhangjiang, Pudong New Area, 201210, Shanghai, China.
Background: Human adipose stromal cells-derived extracellular vesicles (haMSC-EVs) have been shown to alleviate inflammation in acute lung injury (ALI) animal models. However, there are few systemic studies on clinical-grade haMSC-EVs. Our study aimed to investigate the manufacturing, quality control (QC) and preclinical safety of clinical-grade haMSC-EVs.
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