Kaufman L.,NJ |
Gore K.,KDL Gore Solutions Ltd |
Zandee J.C.,Integrated Nonclinical Development Solutions Inc
ILAR Journal | Year: 2016
Despite the efforts, cost, and extensive use of animals for nonclinical research, only a small number of studies have methodically compared findings from animal toxicology studies to those from human clinical trials. Impediments to understanding the translation of nonclinical safety have included the lack of easy access to data and the need for extensive data curation given the diverse terminologies, formats, and data platforms in use. SEND and SDTM study data standards, developed by CDISC and about to become mandated by FDA, can address this and other drug development issues by facilitating access to data in ways that are not currently feasible. A consistent data standard across clinical and nonclinical will discourage the development of data silos, which easily become obstacles to data sharing and maximizing the value of animal and human data. The confluence of rapid scientific advances, increasingly larger quantities of diverse data, technological advances in data mining, and the FDA's requirements for standardized study data create new opportunities for the advancement of drug development and for refinement in the way we use animals. © The Author 2016.
Bolcen S.J.,Centers for Disease Control and Prevention |
Jani N.,NJ |
Lasker B.A.,Centers for Disease Control and Prevention |
Brown J.M.,Centers for Disease Control and Prevention
Clinical Infectious Diseases | Year: 2012
We describe an outbreak of Nocardia cyriacigeorgica soft-tissue infections attributable to unlicensed cosmetic injections and the first report using multilocus sequence typing sequence data for determining Nocardia strain relatedness in an outbreak. All 8 cases identified had a common source exposure and required hospitalization, surgical debridement, and prolonged antimicrobial therapy. © 2012 The Author.
Zhang L.,Environment Canada |
Blanchard P.,Environment Canada |
Gay D.A.,Illinois State Water Survey |
Prestbo E.M.,Tekran Instruments Corporation |
And 10 more authors.
Atmospheric Chemistry and Physics | Year: 2012
Dry deposition of speciated mercury, i.e., gaseous oxidized mercury (GOM), particulate-bound mercury (PBM), and gaseous elemental mercury (GEM), was estimated for the year 2008-2009 at 19 monitoring locations in eastern and central North America. Dry deposition estimates were obtained by combining monitored two-to four-hourly speciated ambient concentrations with modeled hourly dry deposition velocities (V d) calculated using forecasted meteorology. Annual dry deposition of GOM+PBM was estimated to be in the range of 0.4 to 8.1 μ mg -2 at these locations with GOM deposition being mostly five to ten times higher than PBM deposition, due to their different modeled V d values. Net annual GEM dry deposition was estimated to be in the range of 5 to 26 μ mg -2 at 18 sites and 33 μ mg -2 at one site. The estimated dry deposition agrees very well with limited surrogate-surface dry deposition measurements of GOM and PBM, and also agrees with litterfall mercury measurements conducted at multiple locations in eastern and central North America. This study suggests that GEM contributes much more than GOM+PBM to the total dry deposition at the majority of the sites considered here; the only exception is at locations close to significant point sources where GEM and GOM+PBM contribute equally to the total dry deposition. The relative magnitude of the speciated dry deposition and their good comparisons with litterfall deposition suggest that mercury in litterfall originates primarily from GEM, which is consistent with the limited number of previous field studies. The study also supports previous analyses suggesting that total dry deposition of mercury is equal to, if not more important than, wet deposition of mercury on a regional scale in eastern North America. © 2012 Author(s).
Lee Ventola C.,NJ
P and T | Year: 2016
This is the first in a series of two articles about childhood and adult immunization in the United States. Part 2 will discuss adult vaccination, the role of pharmacists, and considerations for P&T committees. © 2016 MediMedia, an ICON Plc company. All Rights Reserved.
Shirodkar P.,Rowan University |
Mehta Y.,Rowan University |
Nolan A.,Rowan University |
Sonpal K.,Rowan University |
And 5 more authors.
Construction and Building Materials | Year: 2011
The objective of this paper is to provide a methodology for determining the degree of partial blending in high RAP mixtures. When RAP is mixed with virgin aggregates and virgin binder, partial blending of RAP binder occurs in the hot mix asphalt. Agencies limit the amount of RAP because the degree of blending between the RAP and the virgin materials is not known. The methodology provides a systematic approach for determining the degree of partial blending in the RAP mixture. The ability to accurately determine the degree of partial blending will help in determining the virgin binder content to be added in the mixture. The degree of partial blending measured from this procedure for 25% RAP by weight of aggregates with PG 70-28 and 35% RAP by weight of aggregates with PG 58-28 are 70% and 96% respectively. © 2010 Elsevier Ltd. All rights reserved.
Chisamore M.J.,NJ |
Hong K.-L.K.,NJ |
Cheng C.,Merck And Co. |
Alves S.E.,NJ |
And 2 more authors.
Biomarkers | Year: 2012
Estrogen Receptor α (ERα) and Estrogen Receptor β (ERβ) are steroid nuclear receptors that transduce estrogen signaling to control diverse physiological processes linked to reproduction, bone remodeling, behavior, immune response and endocrine-related diseases. In order to differentiate between ERα and ERβ mediated effects in vivo, ER subtype selective biomarkers are essential. We utilized ERα knockout (AERKO) and ERβ knockout (BERKO) mouse liver RNA and genome wide profiling to identify novel ERα selective serum biomarker candidates. Results from the gene array experiments were validated using real-time RT-PCR and subsequent ELISA's to demonstrate changes in serum proteins. Here we present data that Lipopolysacharide Binding Protein (LBP) is a novel liver-derived ERα selective biomarker that can be measured in serum. © 2012 Informa UK, Ltd.
Khan M.N.,Mount Sinai School of Medicine |
Baredes S.,NJ |
Eloy J.A.,Center for Skull Base and Pituitary Surgery Neurological Institute of New Jersey Rutgers New Jersey Medical School Newark
International Forum of Allergy and Rhinology | Year: 2014
Background: The purpose of this work was to study the demographics and survival of patients diagnosed with sinonasal adenocarcinoma (SNAC) within the time period of 1973 to 2009 using the Surveillance, Epidemiology, and End Result (SEER) database. Methods: A retrospective cohort study using the U.S. National Cancer Institute's SEER registry was performed to study the demographics and survival for SNAC from 1973 to 2009. Analysis was conducted based on race, gender, and stage. Results: In total, 1270 cases of SNAC were analyzed for demographics and survival. Males accounted for 51.6% of cases, while females accounted for 48.4% of cases, amounting to a male to female ratio of 1.06:1.00. Disease specific survival at 5, 10, 15, and 20 years was 65.2%, 50.9%, 40.9%, and 36.5%, respectively. When analyzed by gender, females had higher survival than males, although this difference was not statistically significant. When analyzed by race, the category of other, which encompasses American Indian, Asian, Hispanic, and unknown or unspecified race, was shown to have the best survival, followed by whites and blacks, respectively. Conclusion: SNAC is a rare tumor classically associated with occupational exposure and carries a variable prognosis. This is the first dedicated large-scale, retrospective analysis of a North American SNAC population. SNAC appears to affect both males and females equally and predominantly affects whites. Patients categorized as other had significantly better survival outcomes, while gender appeared to have no significant effect on survival. © 2014 ARS-AAOA, LLC.
PubMed | NJ
Type: Comparative Study | Journal: The Journal of clinical dentistry | Year: 2012
The goal of this study was to perform an in vitro evaluation of the Spectra, a new caries detector that uses light-induced fluorescence of healthy tooth structure and bacterial pigments to optically detect caries. The Spectra generates a storable color map image of examined tooth surfaces which shows areas of enamel and dentin caries. In this study, Spectra readings of occlusal surfaces were compared to clinical, radiographic, and histological assessments of caries.Two examiners evaluated 41 extracted molars. The teeth were radiographed and then visually assessed. The International Caries Detection and Assessment System (ICDAS) was used to classify the extent of caries. The teeth were then sectioned and assigned a histological score based on the extension of caries into enamel or dentin.Teeth lacking radiographic caries had a mean Spectra reading of 1.5. Teeth having radiographic caries had a mean Spectra reading of 2.0. This difference was statistically significant. In general, higher ICDAS scores were associated with higher Spectra readings. Teeth with histologically evident deep dentin caries had significantly higher Spectra readings than intact teeth or teeth with superficial enamel demineralization. Spectra assessment of occlusal caries agrees with clinical and radiographic methods.Spectra images illustrate the full spectrum of caries severity, from enamel demineralization to dentin decay. The Spectra is a promising technology for the diagnosis and for monitoring the progression of occlusal caries.
PubMed | NJ
Type: Journal Article | Journal: Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals | Year: 2012
Estrogen Receptor (ER) and Estrogen Receptor (ER) are steroid nuclear receptors that transduce estrogen signaling to control diverse physiological processes linked to reproduction, bone remodeling, behavior, immune response and endocrine-related diseases. In order to differentiate between ER and ER mediated effects in vivo, ER subtype selective biomarkers are essential. We utilized ER knockout (AERKO) and ER knockout (BERKO) mouse liver RNA and genome wide profiling to identify novel ER selective serum biomarker candidates. Results from the gene array experiments were validated using real-time RT-PCR and subsequent ELISAs to demonstrate changes in serum proteins. Here we present data that Lipopolysacharide Binding Protein (LBP) is a novel liver-derived ER selective biomarker that can be measured in serum.
PubMed | NJ.
Type: | Journal: Expert opinion on drug safety | Year: 2017
Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management. However, clinicians should be aware of some of the safety concerns of medications used to treat acute and chronic gout. When prescribing medications for gout one has to be mindful of the presence of comorbidities commonly affecting gout patients that may affect drug safety and efficacy, especially in the elderly and in patients treated with multiple drugs. The benefits of gout drugs, usually, outweigh their safety concerns. Studies are needed in gout patients with chronic kidney disease and/or cardiovascular disease, so that escalation of dosing /combination of anti-inflammatory drugs needed to suppress gouty inflammation as well as escalation of dosing/combination of urate lowering drugs needed to achieve target serum urate level will lead to better understanding of gout treatment safety issues.