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FoodandDrugAdministration, etc ; drugs; moieties; pyridines; Show all 4 Subjects
Abstract:
... The nitrogen-bearing heterocycle pyridine in its several analogous forms occupies an important position as a precious source of clinically useful agents in the field of medicinal chemistry research. This privileged scaffold has been consistently incorporated in a diverse range of drug candidates approved by the FDA (Food and Drug Administration). This moiety has attracted increasing attention from ...
FoodandDrugAdministration, etc ; adults; humans; medicine; pathogens; risk; Show all 6 Subjects
Abstract:
... The development of pathogen reduction technologies (PRT) for labile blood components is a long-pursued goal in transfusion medicine. While PRT for red blood cells and whole blood are still in an early phase of development, different PRT platforms for plasma and platelets are commercially available and routinely used in several countries. This review describes complementary strategies recommended b ...
FoodandDrugAdministration, etc ; adjuvants; aluminum; humans; toxicity testing; vaccines; Show all 6 Subjects
Abstract:
... Aluminum salts have been used as adjuvants in human vaccines since 1932. The most used adjuvants are Al oxyhydroxide (AlOOH) and Al hydroxyphosphate (AlOHPO₄). Al adjuvants have different physico-chemical properties. The differences in these properties are not well documented and not considered by the Food and Drug Administration (FDA), though they can largely influence biological effects of the a ...
FoodandDrugAdministration, etc ; brain; brain neoplasms; nucleic acids; therapeutics; Show all 5 Subjects
Abstract:
... Nucleic acid-based therapy emerges as a powerful weapon for the treatment of tumors thanks to its direct, effective, and lasting therapeutic effect. Encouragingly, continuous nucleic acid-based drugs have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Despite the tremendous progress, there are few nucleic acid-based drugs for brain tumors in clinic ...
FoodandDrugAdministration, etc ; dogs; glucose; heparin; therapeutics; veterinary medicine; viability; Show all 7 Subjects
Abstract:
... BACKGROUND: Mesenchymal stem cells (MSCs) have favorable characteristics that render them a potent therapeutic tool. We tested the characteristics of MSCs after temporal storage in various carrier solutions, such as 0.9% saline (saline), 5% dextrose solution (DS), heparin in saline, and Hartmann’s solution, all of which are approved by the U.S. Food and Drug Administration (FDA). Phosphate-buffere ...
FoodandDrugAdministration, etc ; COVID-19 infection; ethics; placebos; vaccines; viruses; Show all 6 Subjects
Abstract:
... The COVID‐19 pandemic due to the novel coronavirus SARS CoV‐2 has inspired remarkable breakthroughs in the development of vaccines against the virus and the launch of several phase 3 vaccine trials in Summer 2020 to evaluate vaccine efficacy (VE). Trials of vaccine candidates using mRNA delivery systems developed by Pfizer‐BioNTech and Moderna have shown substantial VEs of 94–95%, leading the US F ...
FoodandDrugAdministration, etc ; biosensors; commercialization; diagnostic techniques; drugs; immunogenicity; manufacturing; oligonucleotides; Show all 8 Subjects
Abstract:
... The dominance of antibodies in diagnostics has gradually changed following the discovery of aptamers in the early 1990s. Aptamers offer inherent advantages over traditional antibodies, including higher specificity, higher affinity, smaller size, greater stability, ease of manufacture, and low immunogenicity, rendering them the best candidates for point-of-care testing (POCT). In the past 20 years, ...
FoodandDrugAdministration, etc ; COVID-19 infection; lipids; microfluidic technology; nanomedicine; therapeutics; Show all 6 Subjects
Abstract:
... In 2021, mRNA vaccines against COVID-19 were approved by the Food and Drug Administration. mRNA vaccines are important for preventing severe COVID-19 and returning to normal life. The development of RNA-delivery technology, including mRNA vaccines, has been investigated worldwide for ~30 years. Lipid nanoparticles (LNPs) are a breakthrough technology that stably delivers RNA to target organs, and ...
FoodandDrugAdministration, etc ; databases; humans; information management; mariculture; sanitation; shellfish; water quality; Show all 8 Subjects
Abstract:
... In the United States (U.S.), state agencies in charge of mariculture regulation are mandated under the U.S. Food and Drug Administration’s (FDA) National Shellfish Sanitation Program (NSSP) to monitor fecal indicator bacteria (FIB) concentrations, commonly of fecal coliforms, to determine the safety of coastal waters for supporting harvestable shellfish for human consumption. Many states have moni ...
FoodandDrugAdministration, etc ; Salmonella Enteritidis; eggs; farms; food safety; risk; salmonellosis; Tennessee; Show all 8 Subjects
Abstract:
... The Food and Drug Administration Egg Safety Rule requires producers with >3000 layer hens to register a Salmonella enterica serotype Enteritidis (SE) prevention plan for production, storage, and transport of shell eggs. Since its implementation began in 2010, four outbreaks of egg-associated salmonellosis have occurred in Tennessee. We reviewed state health department records from each outbreak an ...
FoodandDrugAdministration, etc ; analytical methods; carcinogenicity; human health; monitoring; smoke; tobacco; toxicology; Show all 8 Subjects
Abstract:
... Tobacco and tobacco smoke contain a complex mixture of over 9500 chemical compounds, many of which have been recognized as hazardous to human health by regulatory agencies. In 2012, the U.S. Food and Drug Administration established a list of harmful and potentially harmful constituents in unburned tobacco and tobacco smoke, 79 of which are considered as carcinogens. Over the past 10 years, with ad ...
FoodandDrugAdministration, etc ; chlorides; ectoparasiticides; nervous system; pharmacodynamics; pharmacokinetics; therapeutics; veterinary medicine; Show all 8 Subjects
Abstract:
... The isoxazolines are a novel class of ectoparasiticides with potent inhibitory activity on glutamate‐ and gamma‐aminobutyric acid‐gated chloride channel located in nervous system of invertebrates. In recent years, studies have been performed to evaluate the efficacy and safety of isoxazolines against various types of ectoparasites, including fleas, ticks, and mites. As more single and combined iso ...
FoodandDrugAdministration, etc ; Codex Alimentarius; calcium; calcium deficiency; energy; energy content; obesity; Show all 7 Subjects
Abstract:
... The calcium content of some foods is inappropriately calculated per 100 kcal, 100 g or 100 mL, or the reference amount customarily consumed (RACC). So, making some food choices based on them to achieve adequate calcium may increase the risks of some chronic diseases. Calculating the calcium content and determining appropriate calcium levels based on the US Food and Drug Administration (FDA), the C ...
FoodandDrugAdministration, etc ; aflatoxins; bioprocessing; color; fungi; oils; oxidation; peanuts; photolysis; ultraviolet radiation; Show all 10 Subjects
Abstract:
... The advanced oxidation processes (AOP) employ free radicals generated from the photolysis of H₂O₂ by UV radiation to decompose the contamination in foods. This study aims at applying AOP to reduce the aflatoxins in peanuts. Radiations in UV-C or UV-A range combined with H₂O₂ solution efficiently degraded aflatoxins in the model solution. The degradation compound, aflatoxin B2a, was also degraded b ...
FoodandDrugAdministration, etc ; acetonitrile; chromatography; fluorouracil; green chemistry; pH; skin neoplasms; sodium acetate; Show all 8 Subjects
Abstract:
... Topical patches containing 5-fluorouracil and imiquimod would significantly improve the shortcomings of the marketed semi-solid formulations for the treatment of non-melanoma skin cancer. As an analytical method is a fundamental part of formulation development, in this study, a simple, accurate, sensitive and greener analytical method was developed and validated for the simultaneous quantification ...
FoodandDrugAdministration, etc ; Alzheimer disease; amyloid; antibodies; cognition; cognitive disorders; memory disorders; neurodegenerative diseases; Show all 8 Subjects
Abstract:
... Alzheimer's disease is a progressive neurodegenerative disease typically presenting with symptoms of memory loss and cognitive decline. Existing theories for the causation of this focuses on amyloid beta plaques and neurofibrillary tau tangles. Most US Food and Drug Administration approved therapies for Alzheimer's disease target cognitive function. A multitude of clinical trials, with a variety o ...
FoodandDrugAdministration, etc ; clinical examination; hyperlipidemia; lipids; meta-analysis; metabolism; nutrition; risk; therapeutics; Europe; Show all 10 Subjects
Abstract:
... Bempedoic acid (BA) is a novel first-in-class oral lipid-lowering therapy. BA has been approved by the European Medicinal Agency and Food and Drug Administration and has been commercialised throughout Europe since the end of 2020 as an add-on therapy in patients at high/very-high cardiovascular risk that are not at LDL-C goals with current lipid-lowering treatments. Recently, Italian lipid managem ...
FoodandDrugAdministration, etc ; bile; cholestasis; databases; excretion; liver; metabolism; mice; research; secretion; ursodeoxycholic acid; Show all 11 Subjects
Abstract:
... Cholestasis is the accumulation of bile acids in the liver due to impaired bile formation, secretion, and excretion caused by infections, drugs, metabolic or genetic diseases. Ursodeoxycholic acid is the only drug approved by the Food and Drug Administration for the treatment of primary biliary cholangitis, but nearly 40% of patients do not adequately respond to this drug and 5–10% show intoleranc ...
FoodandDrugAdministration, etc ; cancer therapy; chemical constituents of plants; drugs; etiology; hepatoma; nutrition; toxicity; Show all 8 Subjects
Abstract:
... The most common principal malignant tumor that accounts for ∼80% of cases of liver cancer across the world is hepatocellular carcinoma (HCC). It is a multifacetedillness that is caused by several risk factors and often progresses in the context of underlying cirrhosis. It is tremendously difficult and essential for the screening of novel therapeutic medications to establish HCC preclinical models ...
FoodandDrugAdministration, etc ; guidelines; hybridization; hyperaccumulators; phytoaccumulation; research; riparian areas; rivers; sediments; sewage; toxicity; India; Show all 12 Subjects
Abstract:
... Thamirabarani river acquires large untreated sewage effluents from the Tirunelveli and Thoothukudi districts of South Tamil Nadu. This study examined the concentration of trace elements in water, sediment, and phytoaccumulation potential of aquatic weeds viz., A. cristata, E. crassipes, S. natans, and P. stratiotes, growing along Srivaikundam dam of Thamirabarani river. The Pb, As, Hg, Cd, and Ni ...