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FDA Research

00:49 EST 21st February 2018 | BioPortfolio

Association of stat6 gene variants with food allergy diagnosed by double-blind placebo-controlled food challenges.

This study describes the role of two STAT6 gene variants in food allergy using data of patients and their parents who underwent double-blind placebo-controlled food challenges (DBPCFCs). After quality control, 369 trios were analyzed including 262 children (71.0%) with food allergy. Associations were tested by family based association testing (FBAT). The A alleles of both SNPs were associated with...

Development of a multiroute physiologically based pharmacokinetic model for orbifloxacin in rabbits.

To predict the orbifloxacin concentrations in rabbits after multiple routes of administration, a flow-limited multiroute physiologically based pharmacokinetic (PBPK) model was developed. Three routes of administration (IV, IM, and PO) were incorporated into this model. Physiological parameters including tissue weights and blood flows through different tissues were obtained from the literature. The...

Pharmacokinetics, pharmacodynamics, and metabolism of acepromazine following intravenous, oral, and sublingual administration to exercised Thoroughbred horses.

Acepromazine is a tranquilizer used commonly in equine medicine. This study describes serum and urine concentrations and the pharmacokinetics and pharmacodynamics of acepromazine following intravenous, oral, and sublingual (SL) administration. Fifteen exercised adult Thoroughbred horses received a single intravenous, oral, and SL dose of 0.09 mg/kg of acepromazine. Blood and urine samples were co...

Testing the validity and reliability of the Self-Administration of Medication (SAM) instrument in Chinese chronic disease patients: A cross-cultural adaptation.

To develop a culturally appropriate and functional standard Mandarin Chinese translation of the Self-Administration of Medication tool and to examine its validity and reliability.

Graphdiyne Nanosheet-Based Drug Delivery Platform for Photothermal/Chemo-therapy Combination Treatment of Cancer.

Nowadays, two-dimensional (2D) materials have attracted extensive attention as cancer drug delivery platforms, owing to their unparalleled physicochemical properties and superior specific surface area. Graphdiyne (GDY) is a novel 2D carbon material. Compared to graphene, GDY not only has benzene rings composed of sp2 hybridized carbon atoms, but also has acetylene units composed of sp hybridized c...

A probabilistic intake model to estimate the impact of reformulation by the food industry among Irish consumers.

This project quantified the impact that voluntary reformulation efforts of the food industry had on the Irish population's nutrient intake. Nutrient composition data on reformulated products were collected from 14 major food companies for two years, 2005 and 2012. Probabilistic intake assessments were performed using the Irish national food consumption surveys as dietary intake data. The nutrient ...

Using Genetically Modified Rodent Models in Drug Development to Explore Target Physiology and Potential Drug Effects.

Infant formulae supplemented with prebiotics: Are they better than unsupplemented formulae? An updated systematic review.

In 2011, the Committee on Nutrition of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition systematically reviewed published evidence related to the safety and health effects of the administration of formulae supplemented with pro- and/or prebiotics compared with unsupplemented formulae. We updated evidence on the effects of the administration of prebiotic-supplemented i...

PEGylated graphene oxide/Fe3O4 nanocomposite: Synthesis, characterization, and evaluation of its performance as de novo drug delivery nanosystem.

This paper describes the development of mitoxantrone-loaded PEGylated graphene oxide/magnetite nanoparticles (PEG-GO/Fe3O4-MTX), and investigation of its preliminary drug delivery performance. For this, the GO was synthesized through oxidizing graphite powder, and subsequently carboxylated using a substitution nucleophilic reaction. The carboxylated GO (GO-COOH) was then conjugated with amine end-...

Halloysite nanotubes-induced Al accumulation and oxidative damage in liver of mice after 30-day repeated oral administration.

Halloysite (AlSiO(OH)·nHO) nanotubes (HNTs) are natural clay materials and widely applied in many fields due to their natural hollow tubular structures. Many in vitro studies indicate that HNTs exhibit a high level of biocompatibility, however the in vivo toxicity of HNTs remains unclear. The objective of this study was to assess the hepatic toxicity of the purified HNTs in mice via oral route. T...

Fabrication of BSA@AuNCs Based Nanostructures for Cell Fluoresce Imaging and Target Drug Delivery.

Drug delivery which can offer efficient and localized drug transportation together with imaging capabilities is highly demanded in the development of cancer theranostic approaches. Herein, we report the construction of bovine serum albumin (BSA) gold nanoclusters (BSA@AuNCs) for cell fluoresce imaging and target drug delivery. BSA@AuNCs were modified with cyclic arginine-glycine-aspartate (cRGD) w...

Brincidofovir as Salvage Therapy for Adenovirus Disease in Intestinal Transplant Recipients.

Adenoviruses are double-stranded DNA viruses that typically cause mild self-limiting respiratory, ocular, and gastrointestinal infections. In immunocompromised patients, especially transplant recipients, the infection can be severe, with dissemination and multiorgan failure. In intestinal transplant recipients, the incidence is as high as 57%. To our knowledge, no standardized guidelines or United...

Enterobacteriaceae Antibiotic Resistance in Ready-to-Eat Foods Collected from Hospital and Community Canteens: Analysis of Prevalence.

Foodborne diseases and antibiotic resistance are serious widespread health problems in the contemporary world. In this study, we compared the microbiological quality of ready-to-eat (RTE) foods found in community canteens versus hospital canteens in Rome, Italy, focusing on detection and quantification of Enterobacteriaceae and the antibiotic resistance of these bacteria. Our findings show a remar...

Propylthiouracil-induced anti-neutrophil cytoplasmic antibody-associated vasculitis mimicking Kawasaki disease.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is rare in children and is characterised as necrotising vasculitis predominantly affecting small and medium-sized vessels. Propylthiouracil (PTU), an antithyroid drug, has been implicated in drug-induced AAV. In contrast, Kawasaki disease (KD) is a common systemic vasculitis, typically observed in children, which affects the m...

γ-Irradiated chitosan based injectable hydrogels for controlled release of drug (Montelukast sodium).

Novel pH-sensitive γ-irradiated low molecular weight chitosan (CS) (pre-irradiated) and poly (vinyl alcohol) (PVA) blended injectable hydrogels, crosslinked with varying concentrations of glycerol, were fabricated for drug delivery application. The effect of low molecular weight irradiated CS on controlled drug release was evaluated to address the problem of higher viscosity and lower solubility ...

Preparation and characterization of antibacterial, eco-friendly edible nanocomposite films containing Salvia macrosiphon and nanoclay.

Nowadays, food security is a vital issue and antimicrobial packaging could play an important role in this matter. In this regard, Salvia macrosiphon seed mucilage (SSM) and nanoclay, as new sources for the production of food-grade edible films were investigated. These edible films were prepared by incorporation of SSM with glycerol and different percentage of nanoclay. Upon addition of nanoclay up...

Junk food advertising moderates the indirect effect of reward sensitivity and food consumption via the urge to eat.

The current study aimed to identify how underlying individual differences increases vulnerability to television food advertising. In particular, this study examined how reward sensitivity, a biologically-based predisposition to approach rewards (such as appetitive foods) in the environment, influenced participants' vulnerability to television food advertising and subsequent food consumption. Ninet...

Mucoadhesive Self-Emulsifying Delivery Systems for Ocular Administration of Econazole.

Development of mucoadhesive self-emulsifying drug delivery systems (SEDDS) providing a prolonged ocular residence time for poorly soluble active pharmaceutical ingredient.

Preparation of a solid self-microemulsifying drug delivery system by hot-melt extrusion.

Hot-melt extrusion (HME) has gained increasing attention in the pharmaceutical industry; however, its potential in the preparation of solid self-emulsifying drug delivery systems (S-SMEDDS) is still unexplored. This study sought to prepare enteric S-SMEDDS by HME and evaluate the effects of the process and formulation variables on S-SMEDDS properties via Box-Behnken design. Liquid SMEDDS were deve...

Effects of Curcuminoids Plus Piperine on Glycemic, Hepatic and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Placebo-Controlled Trial.

Curcuminoids have been shown to reduce glycemia and related complications in diabetes. In the present study, we evaluated the impact of curcuminoids plus piperine administration on glycemic, hepatic and inflammatory biomarkers in type 2 diabetes (T2D) patients.

Frequency and Outcomes of Reduced Dose Non-Vitamin K Antagonist Anticoagulants: Results From ORBIT-AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II).

Non-vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice.

Application of physiologically based pharmacokinetic modeling to the prediction of drug-drug and drug-disease interactions for rivaroxaban.

Rivaroxaban is a direct oral anticoagulant with a large inter-individual variability. The present study is to develop a physiologically based pharmacokinetic (PBPK) model to predict several scenarios in clinical practice.

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model.

In this study, a therapeutic drug monitoring (TDM) of erlotinib in pancreatic cancer patients was performed over 50 weeks to reveal possible alterations in erlotinib plasma concentrations. Additionally, a physiologically based pharmacokinetic (PBPK) model was created to assess such variations in silico.

Estimation of Radionuclide Concentrations and Average Annual Committed Effective Dose due to Ingestion for the Population in the Red River Delta, Vietnam.

Radioactivity concentrations of nuclides of theTh andU radioactive chains andK,Sr,Cs, andPu were surveyed for raw and cooked food of the population in the Red River delta region, Vietnam, using α-, γ-spectrometry, and liquid scintillation counting techniques. The concentration ofK in the cooked food was the highest compared to those of other radionuclides ranging from (23 ± 5) (rice) to (34...

Administration of Lactobacillus plantarum Lp62 to dam rats at the end of delivery and during lactation affects TGF-β1 level and nutritional milk composition, and body weight of pups.

Lactobacillus plantarum Lp62 is a lactic acid bacteria strain that has been isolated from cocoa beans and exhibited probiotic potential. The influence of oral administration of L. plantarum Lp62 on the growth of rat's pups; on yield, cytokines and milk composition was studied.

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