A5046401797- Biosimilars and Bioanalytical Methods
- Carcinogens and Genotoxicity Assessment
- Monoclonal and Polyclonal Antibodies Research
- Environmental Toxicology and Ecotoxicology
- Liver Disease Diagnosis and Treatment
- Alzheimer's disease research and treatments
- Parkinson's Disease Mechanisms and Treatments
- Glutathione Transferases and Polymorphisms
- Diet and metabolism studies
- Biosensors and Analytical Detection
- Microfluidic and Capillary Electrophoresis Applications
- Erythropoietin and Anemia Treatment
- Reproductive biology and impacts on aquatic species
- Advanced Biosensing Techniques and Applications
- Alcohol Consumption and Health Effects
- Plant and animal studies
- Pharmaceutical studies and practices
- HER2/EGFR in Cancer Research
- Banana Cultivation and Research
- Effects and risks of endocrine disrupting chemicals
- Genomics, phytochemicals, and oxidative stress
- Antibiotics Pharmacokinetics and Efficacy
- Estrogen and related hormone effects
- Endoplasmic Reticulum Stress and Disease
- Animal Genetics and Reproduction
Covance (United States)
2012-2020
Research Triangle Park Foundation
2001
Duke University
1996-1999
University of Wisconsin–Madison
1990-1992
Mount Desert Island Biological Laboratory
1991
State University of New York
1990
Morphological changes in the lungs of macaques induced by several different LRRK2 inhibitors are reversible and do not lead to lung deficits.
Trastuzumab (Herceptin(®)) is a humanized monoclonal antibody (mAb) that binds to the HER2 protein. PF-05280014 being developed as potential biosimilar trastuzumab products marketed in United States (trastuzumab-US) and European Union (trastuzumab-EU). Nonclinical studies were designed evaluate similarity of trastuzumab-US trastuzumab-EU using vitro structural functional analyses, vivo pharmacokinetic immunogenicity assessments.Peptide mapping was utilized determine similarity. Functional...
Dried blood spot (DBS) sampling has gained considerable interest as a microsampling technique to support drug discovery and development owing its enormous ethical practical benefits. Quantitative determinations of drugs and/or their metabolites collected in DBS matrix current format, however, have encountered technical challenges regulatory uncertainty. The bioanalysis are largely ascribed the way how samples analyzed. Currently, an uncontrolled amount sample, e.g. 20 µl, is per time point...
Comparative nonclinical studies were conducted with the proposed biosimilar PF-05280586 and rituximab-EU (MabThera®). In side-by-side analyses, peptide maps complement-dependent cytotoxicity assay results similar. Sexually-mature cynomolgus monkeys administered or as a single dose of 0, 2, 10, 20 mg/kg on day 1 observed for 92 days (single-dose study) 5 weekly injections 0 necropsied 30, after 5th dose, 121 (repeat-dose study). The pharmacokinetic pharmacodynamic profiles both molecules...
Abstract Although antipredator behavior of threespine stickleback has been extensively studied in the laboratory, interactions between and their predators nature have never described. This paper describes territorial male four on males or young they guard. Two predators, cutthroat trout a hemipteran nymph (Belostomatidae), prey but not young. Another, roughskin newt, is potential predator does pose threat to males. Prickly sculpin both offspring that Differences toward indicate are capable...
Abstract Putative gain-of-function mutations in leucine-rich repeat kinase 2 (LRRK2), resulting increased activity and cellular toxicity, are a leading genetic cause of Parkinson’s disease (PD). Hence, there is strong interest developing LRRK2 inhibitors as disease-modifying therapy. Published reports that dosing with two (GNE-7915 GNE-0877) induce histopathological changes the lung non-human primates Fuji et al. 2015 ( 1 ) raised concerns about potential safety liability inhibitors. In...
Background: Liquid microsampling can realize ethical benefits through reduced animal usage. It inherently deals with a minute amount of sample; for example, <30 µl plasma, which is generally insufficient multiple analyses. Results: We report accurate weighing and dilution-assisted plasma (AWADA-PM) that substantially increases sample sizes (e.g., by tenfold). Plasma samples are harvested from blood (∼70 µl) in capillaries. The weighed calibrated balance. weights converted to volumes using...
Abstract Developing a method for isolating skate ( Raja erinacea ) basolateral liver plasma membranes, as well characterizing the lipid composition and fluidity of these was primary purpose this study. Membranes were isolated using self‐generating Percoll gradients. Marker enzyme studies indicate that preparation is highly enriched in domain membrane largely free contamination by intracellular organelles or canalicular membranes. Further, membranes contain agency responsible Na + ‐dependent...
<h3>Background</h3> Rituximab is a genetically-engineered chimeric mouse/human IgG1 cytolytic monoclonal antibody (mAb) targeting the CD20 antigen present on surface of B cells and approved for treatment non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis. PF-05280586 being developed as potential biosimilar to rituximab. <h3>Objectives</h3> hese studies were designed evaluate whether rituximab-EU (MabThera<sup>®</sup>) similar using structural, in...
Chronic ethanol consumption reduces alanine transport by rat basolateral liver plasma membrane (blLPM) vesicles; however, the mechanism for this effect remains uncertain. It may be related to ethanol-induced changes in blLPM fluidity and lipid composition; alternatively might reduce number of transporters blLPM. To investigate composition on Na(+)-dependent uptake these parameters were altered vitro. Increasing had no vesicles or activity amino acid systems, A ASC. Because is known...