Peer-Reviewed
Publications

Open access, peer-reviewed publications ensure that knowledge is a public good. HESI believes that accessible research is critical for equitable engagement, diverse collaboration, and increased interdisciplinary conversation. We strive to achieve open access on all publications, and more than 200 publications from HESI programs have been published in the last decade.

Impact of HESI Publications
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Can We Panelize Seizure?

Toxicological Sciences, 2020

Roberts R, Authier S, Mellon D, Morton M, Suzuki I, Tjalkens RB, ...

Seizure liability remains a significant cause of attrition in drug discovery and development, leading to loss of competitiveness, delays and increased costs. Current detection methods rely on observations made in in vivo studies intended to support clinical trials, such as tremors or other abnormal movements. These signs ...

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Repolarization Studies Using Human Stem Cell-Derived Cardiomyocytes: Validation Studies and Best Practice Recommendations

Regulatory Toxicology and Pharmacology, 2020

Gintant G, Kaushik EP, Feaster T, Stoelzle-Feix S, Kanda Y, ...

Human stem cell-derived cardiomyocytes (hSC-CMs) hold great promise as in vitro models to study the electrophysiological effects of novel drug candidates on human ventricular repolarization. Two recent large validation studies have demonstrated the ability of hSC-CMs to detect drug-induced delayed ...

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Use of the ZDF Rat to Model Dietary Fat Induced Hypercoagulability is Limited by Progressive and Fatal Nephropathy

Journal of Pharmacological and Toxicological Methods, 2020

Pugsley MK, Brooks MB, Fishman CE, Katavolos P, Chiang AY, ...

Zucker diabetic fatty (ZDF) rats are used widely as an animal model of metabolic syndrome and insulin resistance. Our study focused on the effects of high versus low dietary fat on the development of Type 2 diabetes in obese male ZDF rats (fa/fa), including biomarkers to detect early signs of hypercoagulability and vascular injury ...

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Development of the First Reference Antibody Panel for Qualification and Validation of Cytokine Release Assay Platforms: Report of an International Collaborative Study

Cytokine, 2020

Vessillier S, Fort M, O'Donnell L, Hinton H, Nadwodny K, ...

Author links open overlay Immunomodulatory therapeutics such as monoclonal antibodies (mAb) carry an inherent risk of undesired immune reactions. One such risk is cytokine release syndrome (CRS), a rapid systemic inflammatory response characterized by the secretion of pro-inflammatory cytokines from immune cells. It is ...

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Direct RT-qPCR Detection of SARS-CoV-2 RNA From Patient Nasopharyngeal Swabs Without an RNA Extraction Step

PLOS Biology, 2020

Bruce EA, Huang ML, Perchetti GA, Tighe S, Laaguiby P, Hoffman JJ, ...

The ongoing COVID-19 pandemic has created an unprecedented need for rapid diagnostic testing. The World Health Organization (WHO) recommends a standard assay that includes an RNA extraction step from a nasopharyngeal (NP) swab followed by reverse transcription–quantitative polymerase chain reaction (RT-qPCR) to detect ...

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Improving the Environmental Risk Assessment of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials (UVCBs)

Environmental Toxicology and Chemistry, 2020

Salvito D, Fernandez M, Jenner K, Lyon DY, de Knecht J, Mayer P, ...

Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) pose unique risk assessment challenges to regulators and to product registrants. These substances can contain many constituents, sometimes partially unknown and/or variable, depending on fluctuations in their ...

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