A5030606422- Gut microbiota and health
- Clostridium difficile and Clostridium perfringens research
- Pancreatitis Pathology and Treatment
- Probiotics and Fermented Foods
- Pancreatic and Hepatic Oncology Research
- Air Quality and Health Impacts
- Opioid Use Disorder Treatment
- Biomarkers in Disease Mechanisms
- Antibiotic Resistance in Bacteria
- Neonatal Respiratory Health Research
- MicroRNA in disease regulation
- Phagocytosis and Immune Regulation
- Pancreatic function and diabetes
- Health Systems, Economic Evaluations, Quality of Life
- Neuroscience of respiration and sleep
- Asthma and respiratory diseases
- Immunotoxicology and immune responses
- Diabetes Treatment and Management
- Urinary Tract Infections Management
- Iron Metabolism and Disorders
- Statistical Methods in Clinical Trials
- Energy and Environment Impacts
- Clinical Laboratory Practices and Quality Control
- Pharmacogenetics and Drug Metabolism
- Chronic Kidney Disease and Diabetes
Center for Drug Evaluation and Research
2016-2025
United States Food and Drug Administration
2016-2025
Food and Drug Administration
2020
Committee on Publication Ethics
2019
Centre for Innovation in Regulatory Science
2018
Louisiana State University
2007-2008
Louisiana State University Agricultural Center
2008
New England Biolabs (United States)
1981
Abstract Background Emergence of antibiotic resistance is a global public health concern. The relationships between use, the gut community composition, normal physiology and metabolism, individual are still being defined. Shifts in composition bacteria, genes (ARGs) mobile genetic elements (MGEs) after treatment not well-understood. Methods This project used next-generation sequencing, custom-built metagenomics pipeline differential abundance analysis to study effect monotherapy on resistome...
Fetal stress has been linked to adult atherosclerosis, obesity, and diabetes. Epidemiology studies have associated fetal exposure maternal smoking postnatal environmental tobacco smoke (ETS) with increased asthma risk.We tested the hypothesis, in a mouse model of asthma, that utero ETS alters airway function respiratory immune responses adults.Pregnant Balb/c mice were exposed daily or HEPA-filtered air (AIR). Offspring inhaled aerosolized ovalbumin (OVA) saline weeks 7-8. Regardless whether...
The ability of nanoparticles to form larger superstructures aggregates and agglomerates has been extensively noted in the literature. vivo biological impact these structures, however, not assessed. This knowledge gap is especially critical safety assessment be used for therapeutic purposes.Here we show that when administered intravenously into a mouse model, gold nanoparticle reversible irreversible demonstrate significant differences organ cellular distribution compared with primary...
Mild injury of the exocrine pancreas is often asymptomatic and can be under- or mis-diagnosed. The pancreas-enriched microRNAs miR-216a miR-217 were evaluated as potential serum biomarkers in rodent models acute pancreatitis induced by caerulein, l-arginine, pancreatic duct ligation. Both showed time- dose- relevant responses to wider dynamic ranges response than amylase lipase. Pancreas-selective found relatively sensitive rodents with potentially greater specificity current standard assays.
To ensure US patients realize the public health benefit of a robust, competitive market for biosimilar products, Food and Drug Administration (FDA) is focused on improving efficiency development approvals. As comparative clinical studies can be costly time consuming, FDA currently conducting research to inform agency's thinking critical aspects use pharmacodynamic (PD) biomarkers demonstrate biosimilarity, which either streamline or negate need studies. A biological product that highly...
As nanoparticles (NPs) become more prevalent in the pharmaceutical industry, questions have arisen from both industry and regulatory stakeholders about long term effects of these materials. This study was designed to evaluate whether gold (10 nm), silver (50 or silica nm) administered intravenously mice for up 8 weeks at doses known be sub-toxic (non-toxic single acute repeat dosing levels) clinically relevant could produce significant bioaccumulation liver spleen macrophages. Repeated with...
Abstract Introduction According to the Centers for Disease Control’s 2015 Hospital Acquired Infection Prevalence Survey, 1 in 31 hospital patients was infected with at least one nosocomial pathogen while being treated unrelated issues. Many studies associate antibiotic administration infection occurrence. However, our knowledge, there is little no direct evidence of selecting opportunistic pathogens. Aim This study aims confirm gut microbiota shifts an animal model treatment determine...
Emerging approaches show promise for regulatory use.
We previously described the physicochemical characteristics (particle size, adsorbed polynuclear aromatic hydrocarbons [PAHs], oxygen, and metal content) of butadiene soot (BDS) nanoparticles generated during incomplete combustion high-volume industrial petrochemical, 1,3-butadiene. also demonstrated localization BDS-delivered PAHs to lipid droplets murine human respiratory cells in vitro up-regulation biotransformation oxidative stress responses these cells. Here, objective was determine...
<h3>Importance</h3> In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine contained probable human carcinogen<i>N</i>-nitrosodimethylamine (NDMA). addition, petitioner proposed could convert to NDMA in humans; however, this was primarily based on small clinical study detected an increase urinary excretion of after oral consumption. <h3>Objective</h3> To evaluate 24-hour administration compared with placebo. <h3>Design, Setting,...
In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, approaches to assess safety, efficacy, quality, performance of FDA-regulated products. line with this, Division Applied Regulatory Science was created move into Center Drug Evaluation Research (CDER) review process close gap between scientific innovation review. The Division, located in Office Clinical Pharmacology, is unique it performs...
Combustion-generated radicals interact to form polynuclear aromatic hydrocarbons (PAHs), including carcinogens. PAHs aggregate into 20- 50-nm particles, which extend branched-chain structures (soots). Incomplete combustion yields black soot particles and smoke. Many PAHs, those in soots, fluoresce upon excitation. We have reported that butadiene (BDS), generated during of the high-volume petrochemical 1,3-butadiene, serves as a reproducible example combustion-derived fine ultrafine with...
Contrast-induced nephropathy (CIN) refers to a decline in renal function following exposure iodinated contrast media (CM). The present study was initiated explore the role of known human risk factors (spontaneous hypertension, diabetes, protein-losing nephropathy) on CIN development rodent models and determine effect CM administration kidney injury biomarkers face preexisting injury. Spontaneously hypertensive rats (hypertension), streptozotocin-treated Sprague Dawley (diabetes), Dahl...
Three classical rodent models of acute pancreatitis were created in an effort to identify potential pre-clinical drug-induced (DIP) and candidate non-invasive biomarkers for improved detection DIP. Study objectives included designing a lexicon minimize bias by capturing normal variation spontaneous injury-induced changes while maintaining the ability statistically differentiate degrees change, defining morphologic anchors novel pancreatic injury biomarkers, understanding mechanisms...
Importance Opioids can cause severe respiratory depression by suppressing feedback mechanisms that increase ventilation in response to hypercapnia. Following the addition of boxed warnings benzodiazepine and opioid products about increased risk with simultaneous use, US Food Drug Administration evaluated whether other drugs might be used place benzodiazepines may similar effects. Objective To study combining paroxetine or quetiapine oxycodone, compared oxycodone alone, decreases ventilatory...