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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Application of New Statistical Distribution Approaches for Environmental Mixture Risk Assessment: A Case Study

Science of the Total Environment, 2019

Kienzler A, Bopp S, Halder M, Embry MR, Worth A

There is growing evidence that single substances present below their individual thresholds of effect may still contribute to combined effects. Here, the possible use of ecotoxicological threshold concentrations of no concern (i.e. 5th percentile of statistical distribution of ecotoxicological values) is investigated to ...

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Tumorigenicity Assessment of Cell Therapy Products: The Need for Global Consensus and Points to Consider

Cytotherapy, 2019

Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, ...

Pluripotent stem cells offer the potential for an unlimited source for cell therapy products. However, there is concern regarding the tumorigenicity of these products in humans, mainly due to the possible unintended contamination of undifferentiated cells or transformed cells. Here, we critically review currently available ...

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A Cross-Sector Call to Improve Carcinogenicity Risk Assessment Through Use of Genomic Methodologies

Regulatory Toxicology and Pharmacology, 2019

Yauk CL, Harrill AH, Ellinger-Ziegelbauer H, van der Laan JW, ...

Robust genomic approaches are now available to realize improvements in efficiencies and translational relevance of cancer risk assessments for drugs and chemicals. The authors propose a path for implementation of innovative cancer risk assessment including incorporating genomic signatures to assess mechanistic relevance ...

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Electrophysiological Characterization of Drug Response in hSC-Derived Cardiomyocytes Using Voltage-Sensitive Optical Platforms

Journal of Pharmacological and Toxicological Methods, 2019

Pfeiffer-Kaushik ER, Smith GL, Cai B, Dempsey GT, ...

Voltage-sensitive optical (VSO) sensors offer a minimally invasive method to study the time course of repolarization of the cardiac action potential (AP). This Comprehensive in vitro Proarrhythmia Assay (CiPA) cross-platform study investigates protocol design and measurement variability of VSO sensors for ...

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Comparison of Immune System Development in Nonclinical Species and Humans: Closing Information Gaps for Immunotoxicity Testing and Human Translatability

Reproductive Toxicology, 2019

Skaggs H, Chellman GJ, Collinge M, Enright B, Fuller CL, Krayer J, ...
  • HESI - Health and Environmental Sciences Institute

The developmental origins of human health and disease (DOHaD) is a growing field of health-related research that is based on the hypothesis that perturbations to the pre- or postnatal environment, in the form of xenobiotic exposure, stress, infections or nutritional deficits, may contribute to the manifestation of disease ...

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