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2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Bioanalysis
January 2025
Eli Lilly and Company, Indianapolis, IN, USA.
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.
View Article and Find Full Text PDFUnveiling the role of miRNAs in Diminished Ovarian Reserve: an in silico network approach.
Syst Biol Reprod Med
December 2025
Department of Biosciences and Technology for Food, Agriculture and Environment, University of Teramo, Teramo, Italy.
MicroRNAs (miRNAs) have acquired an increased recognition to unravel the complex molecular mechanisms underlying Diminished Ovarian Reserve (DOR), one of the main responsible for infertility. To investigate the impact of miRNA profiles in granulosa cells and follicular fluid, crucial players in follicle development, this study employed a computational network theory approach to reconstruct potential pathways regulated by miRNAs in granulosa cells and follicular fluid of women suffering from DOR. Available data from published research were collected to create the FGC_MiRNome_MC, a representation of miRNA target genes and their interactions.
View Article and Find Full Text PDFEmerging Pharmacological Interventions for Chronic Venous Insufficiency: A Comprehensive Systematic Review and Meta-Analysis of Efficacy, Safety, and Therapeutic Advances.
Pharmaceutics
January 2025
Multidisciplinary Laboratory of Scientific Evidence, University Center of Mineiros (Unifimes), Mineiros 75833-130, GO, Brazil.
Chronic Venous Insufficiency (CVI) is a progressive vascular condition characterized by venous hypertension and chronic inflammation, leading to significant clinical and socioeconomic impacts. This study aimed to evaluate the efficacy and safety of emerging pharmacological interventions for CVI, focusing on clinical outcomes such as pain, edema, cutaneous blood flow, and quality of life. Eligible interventions comprised new vasoprotective drugs, such as hydroxyethylrutoside, Pycnogenol, aminaphthone, coumarin + troxerutin, and Venoruton, compared to the standard therapy of diosmin and hesperidin.
View Article and Find Full Text PDFMaternal and Infant Characteristics and Pumping Profiles of Women That Predominantly Pump Milk for Their Infants.
Nutrients
January 2025
School of Molecular Sciences, The University of Western Australia, Crawley, WA 6009, Australia.
Background: Whilst it is inconvenient and time-intensive, predominantly (PP) and exclusively pumping (EP) mothers rely on breast expression to provide milk for their infants and to ensure continued milk supply, yet these populations are poorly understood.
Methods: We assessed and characterised Western Australian PP mothers ( = 93) regarding 24 h milk production (MP) and infant milk intake and demographics, perinatal complications and breastfeeding difficulties, the frequencies of which were compared with published general population frequencies. Pumping efficacy and milk flow parameters during a pumping session in PP mothers ( = 32) were compared with those that pump occasionally (reference group, = 60).
The Impact of a Very-Low-Calorie Ketogenic Diet on Monocyte Subsets of Patients with Obesity: A Pilot Study.
Nutrients
January 2025
Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza University of Rome, 00161 Rome, Italy.
Obesity is closely linked to chronic low-grade inflammation and the development of cardio-metabolic comorbidities. Monocyte subsets, which are crucial in immune responses, have been reported to be altered in individuals with obesity, potentially exacerbating inflammation. Although very-low-calorie ketogenic diets (VLCKDs) are recognized for their efficacy in promoting weight loss and improving metabolic health, their impact on circulating monocyte subsets remains poorly understood.
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