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A weight of evidence review on the mode of action, adversity, and the human relevance of xylene's observed thyroid effects in rats.
Crit Rev Toxicol
January 2025
Product Stewardship, Science & Regulatory, Shell Global Solutions International B.V. The Hague, the Netherlands.
Xylene substances have wide industrial and consumer uses and are currently undergoing dossier and substance evaluation under Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) for further toxicological testing including consideration of an additional neurotoxicological testing cohort to an extended one-generation reproduction toxicity (EOGRT) study. New repeated dose study data on xylenes identify the thyroid as a potential target tissue, and therefore a weight of evidence review is provided to investigate whether or not xylene-mediated changes on the hypothalamus-pituitary-thyroid (HPT) axis are secondary to liver enzymatic induction and are of a magnitude that is relevant for neurological human health concerns. Multiple published studies confirm xylene-mediated increases in liver weight, hepatocellular hypertrophy, and liver enzymatic induction the oral or inhalation routes, including an increase in uridine 5'-diphospho-glucuronosyltransferase (UDP-GT) activity, the key step in thyroid hormone metabolism in rodents.
View Article and Find Full Text PDFBackground: Extracellular vesicles (EVs) are lipid bilayer nanoparticles (30-10,000 nm) released from all cells that facilitate cell-to-cell communication. Cell type-specific EVs can be enriched using cell-specific surface markers. Neuronal-enriched EVs (NEVs) contain measurable neurotrophins, pro- and mature brain-derived neurotrophic factor (BDNF), that have opposing action in neuronal plasticity.
View Article and Find Full Text PDFA Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled-Release Formulations Versus a Marketed Orlistat Product.
Clin Pharmacol Drug Dev
January 2025
Empros Pharma AB, Solna, Sweden.
A new modified-release oral formulation combines acarbose and orlistat (MR-OA) to enhance efficacy and reduce adverse effects through controlled drug release. This study aims to compare the pharmacodynamic properties of the orlistat component of MR-OA (MR-O) with a conventional orlistat product, Xenical (Conv-O), analyzing the percentage of fecal fat excretion. In addition, the pharmacokinetic properties of the complete formulation, MR-OA, were compared with Conv-O.
View Article and Find Full Text PDFBackground: Alzheimer's disease (AD) is characterized by the extracellular accumulation of senile plaques composed of beta-amyloid (Aβ) and the intracellular deposition of neurofibrillary tangles composed of hyperphosphorylated tau (Tp). Aβ induces a chronic neuroinflammation that contributes to the neurite network disorganization and finally neuronal death. Lecanemab, a humanized monoclonal antibody (Ab) that recognizes protofibrils/oligomers and prevents Aβ deposition, is the first US approved Ab for AD.
View Article and Find Full Text PDFBackground: We aim to repurpose the widely used adjuvant and immunomodulator Alhydrogel at a specific dose and schedule (AD04) as a disease-modifying treatment for mild Alzheimer's disease (AD). AD04 is a potent adjuvant commonly used in vaccines and allergy immunotherapies to augment the magnitude and durability of the immune response. Our preliminary data come from a clinical Phase 2 study in which AD04 served as a control arm.
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