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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An Evaluation Framework for New Approach Methodologies (NAMs) for Human Health Safety Assessment

Regulatory Toxicology and Pharmacology, 2020

Stanley T. Parish, Michael Aschner, Warren Casey, Marco Corvaro, ...
  • HESI - Health and Environmental Sciences Institute

The need to develop new tools and increase capacity to test pharmaceuticals and other chemicals for potential adverse impacts on human health and the environment is an active area of development. The response to these challenges for a “paradigm shift” toward using new approach methodologies (NAMS) for safety assessment has ...

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Summary of a Workshop on Preclinical and Translational Safety Assessment of CD3 Bispecifics

Journal of Immunotoxicology, 2020

Kamperschroer C, Shenton J, Lebrec H, Leighton JK, Moore PA, ...

Currently, there is a multitude of CD3 bispecifics with different molecular designs and binding properties in preclinical and clinical development for the treatment of liquid or solid tumors. The key safety concerns with CD3 bispecifics are excessive release of cytokines, which may translate to potentially life-threating ...

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Cross-Company Evaluation of the Human Lymphocyte Activation Assay

Journal of Immunotoxicology, 2020

Collinge M, Schneider P, Li D, Parish S, Dumont C, Freebern W, ...

Nonclinical immunotoxicity evaluation is an important component of safety assessment for pharmaceuticals. One in vitro assay that can be applied in a weight of evidence assessment is the human lymphocyte activation (HuLA) assay, an antigen recall assay, similar in many respects to the in vivo T-cell-dependent ...

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Cross-Site and Cross-Platform Variability of Automated Patch Clamp Assessments of Drug Effects on Human Cardiac Currents in Recombinant Cells

Nature Scientific Reports, 2020

Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, ...

Automated patch clamp (APC) instruments enable efficient evaluation of electrophysiologic effects of drugs on human cardiac currents in heterologous expression systems. Differences in experimental protocols, instruments, and dissimilar site procedures affect the variability of IC50 values characterizing drug block ...

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Ontogeny and Cross-Species Comparison of Pathways Involved in Drug Absorption, Distribution, Metabolism, and Excretion in Neonates (Review): Kidney

Drug Metabolism and Disposition, 2020

Bueters R, Bael A, Gasthuys E, Chen C, Schreuder MF, Frazier KS
  • HESI - Health and Environmental Sciences Institute

This review provides insight in cross-species developmental differences of absorption, distribution, metabolism, and excretion properties in the kidney, which should be considered in neonate/juvenile study interpretation, hypotheses generation, and experimental design.

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‘All In’: A Pragmatic Framework for COVID‐19 Testing and Action on a Global Scale

EMBO Molecular Medicine, 2020

Pettit SD, Jerome KR, Rouquie D, Mari B, Barbry P, Kanda Y, ...
  • HESI - Health and Environmental Sciences Institute

Current demand for SARS‐CoV‐2 testing is straining material resource and labor capacity around the globe. As a result, the public health and clinical community are hindered in their ability to monitor and contain the spread of COVID‐19. Despite broad consensus that more testing is needed, pragmatic guidance towards ...

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