A5101439830- Drug Solubulity and Delivery Systems
- Cannabis and Cannabinoid Research
- Analytical Chemistry and Chromatography
- Edible Oils Quality and Analysis
- Drug Transport and Resistance Mechanisms
- Pancreatic function and diabetes
- Pharmacogenetics and Drug Metabolism
- Carcinogens and Genotoxicity Assessment
- Pharmacological Effects of Natural Compounds
- 3D Printing in Biomedical Research
- Alcohol Consumption and Health Effects
- Analytical Methods in Pharmaceuticals
- Dye analysis and toxicity
- Chemical Reaction Mechanisms
- Bipolar Disorder and Treatment
- Diabetes Treatment and Management
- Coordination Chemistry and Organometallics
- Poisoning and overdose treatments
- Plant Taxonomy and Phylogenetics
- Protein purification and stability
- Potato Plant Research
- Diabetes Management and Research
- Phytochemical compounds biological activities
- Diet, Metabolism, and Disease
- Fatty Acid Research and Health
United States Food and Drug Administration
2009-2025
Nanchang University
2025
Center for Food Safety and Applied Nutrition
2019-2024
Applied Research (United States)
2024
Center for Drug Evaluation and Research
2016-2021
University of Pittsburgh
2016
Abstract Background Transcriptomic benchmark concentration (BMC) modeling provides quantitative toxicogenomic information that is increasingly being used in regulatory risk assessment of data poor chemicals. Over the past decade, RNA sequencing (RNA-seq) gradually replacing microarray as major platform for transcriptomic applications due to its higher precision, wider dynamic range, and capability detecting novel transcripts. However, it unclear whether RNA-seq offers substantial advantages...
Microphysiological systems (MPS), such as organ-on-a-chip platforms, are an emerging alternative model that may be useful for predicting human physiology and/or toxicity. Due to the interest in these Center Food Safety and Applied Nutrition partnered with Emulate evaluate utility of Beta Human Liver Emulation System (BHLES) its regulatory science program. Using known hepatotoxic compounds (usnic acid, benzbromarone, tamoxifen, acetaminophen) have no reported cases liver toxicity (dimethyl...
Cannabidiol (CBD) has been reported to induce hepatotoxicity in clinical trials and research studies; however, little is known about the safety of other nonintoxicating cannabinoids. New approach methodologies (NAMs) based on bioinformatic analysis high-throughput transcriptomic data are gaining increasing importance risk assessment regulatory decision-making data-poor chemicals. In current study, we conducted a concentration response hemp extract its four major constituent cannabinoids...
3-chloro-1,2-propanediol (3-MCPD) and 3-MCPD esters are contaminants present in a variety of processed foods, including infant formulas. Toxicological data unavailable humans, but rodent studies have demonstrated renal testicular toxicity from esters. There is evidence that hydrolyzed the digestive system, releasing would be absorbed induce damage. We assessed absorption metabolism three monoesters, 1-oleoyl (1-Ol), 1-linoleoyl (1-Li) 1-palmitoyl (1-Pa) commonly found U.S. formula using...
To improve the oral absorption of relugolix (RLGL), which has low bioavailability due to its solubility and being a substrate P-glycoprotein (P-gp). A solid self-microemulsifying drug delivery system (RLGL-S-SMEDDS) was prepared evaluated in vitro vivo. The composition (S-SMEDDS) selected by study pseudo-ternary phase diagram, further optimized Design-Expert optimization design. RLGL-S-SMEDDS were terms particle size, zeta potential, morphology analysis, thermodynamic stability, release,...
Microphysiological systems (MPS) are emerging as potentially predictive models for drug safety and toxicity assessment. To assess the utility of these systems, Food Drug Administration partnered with Emulate to evaluate Human Liver Organ-Chip in a regulatory setting. Diglycolic acid (DGA), known hepatotoxin, was evaluated Liver-Chip compared multi-well plate format Liver-Chip's capabilities, limitations, overall performance, concordance other vivo vitro studies. Cryopreserved primary human...
Abstract Hemp extracts and consumer products containing cannabidiol (CBD) and/or other phytocannabinoids derived from hemp have entered the marketplace in recent years. CBD is an approved drug United States for treatment of certain seizure disorders. While effects liver been well characterized, data on cannabinoids methods studying these vitro are limited. This study examined hepatotoxic potential CBD, concentration‐matched extract, cannabinol (CBN), at consumer‐relevant concentrations...
Fatty acid esters of 3-monochloropropane-1,2-diol (3-MCPD) are chemical contaminants found in a wide range edible oils that thermally processed during industrial manufacturing infant formula and other lipid-containing foods the United States. Rodent studies have unequivocally demonstrated plethora vivo toxicological effects including reproductive, neurological renal dysfunction. To determine if similar observed human organ systems, vitro using cell lines conducted to assess concordance data...
3-Monochloropropane-1,2-diol (3-MCPD) is a food processing contaminant in the U.S. supply, detected infant formula. In vivo rodent model studies have identified variety of possible adverse outcomes from 3-MCPD exposure including renal effects like increased kidney weights, tubular hyperplasia, necrosis, and chronic progressive nephropathy. Given lack available toxicological assessments humans limited availability vitro human cell studies, health remain unclear. We used proximal tubule cells...
Consumer use of cannabidiol (CBD) is growing, but there are still data gaps regarding its possible adverse effects on reproduction and development. Multiple pathways signaling cascades involved in organismal development neuronal function, including endocannabinoid synthesis systems, well conserved across phyla, suggesting that
Mitiglinide is a widely used agent for diabetic treatment. We established pharmacokinetic-pharmacodynamic (PK-PD) model to illustrate the relationship between mitiglinide plasma concentration and its glucose lowering effects in healthy volunteers. The volunteers participated test after administration of single dose 10 mg mitiglinide. drug Plasma values levels were determined by LC-MS/MS assay hexokinase method. A PK-PD was with series equations describe medicine glucose, solved numerically...
A routine, selective and sensitive ultra-high performance liquid chromatography-electrospray ionisation tandem triple quadrupole mass spectrometry (UHPLC-ESI-MS/MS) method was developed validated for the quantification of 3-monochloropropane-1,2-diol (3-MCPD) in Caco-2 cell transport buffer (FaSSIF-V2, second version a fasted state simulated intestinal fluid) receiving (HBSS, Hank's balanced salt solution). The involves measuring deuterated 3-MCPD (3-MCPD-d5) as internal standard (IS) during...