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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Utility of a next-generation framework for assessment of genomic damage: A case study using the pharmaceutical drug candidate etoposide

Environmental and Molecular Mutagenesis, 2021

Nicolette J, Luijten M, Sasaki JC, Custer L, Embry M, Froetschl R, ...

The HESI Genetic Toxicology Technical Committee (GTTC) applies their systematic and flexible approach for assessing the risk of genetic damage due to exposure to chemical substances to etoposide, a drug used in certain types of cancer treatments, as a representative pharmaceutical case study.

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Incorporating Human Exposure Information in a Weight of Evidence Approach to Inform Design of Repeated Dose Animal Studies

Regulatory Toxicology and Pharmacology, 2021

Lowe K, Dawson J, Phillips K, Minucci J, Wambaugh JF, Qian H, ...

Human health risks from chronic exposures to environmental chemicals are typically estimated from potential human exposure estimates and dose-response data obtained from repeated-dose animal toxicity studies. Various criteria are available for selecting the top (highest) dose used in these animal studies. For example, ...

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Opportunities and Challenges Related to Saturation of Toxicokinetic Processes: Implications for Risk Assessment

Regulatory Toxicology and Pharmacology, 2021

Tan YM, Barton HA, Boobis A, Brunner R, Clewell H, Cope R, ...

Top dose selection for repeated dose animal studies has generally focused on identification of apical endpoints, use of the limit dose, or determination of a maximum tolerated dose (MTD). The intent is to optimize the ability of toxicity tests performed in a small number of animals to detect effects for hazard identification. An ...

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Nonclinical Safety Assessment of Engineered T Cell Therapies

Regulatory Toxicology and Pharmacology, 2021

Lebrec H, Maier CC, Maki K, Ponce R, Shenton J, & Green S

Over the last decade, immunotherapy has established itself as an important novel approach in the treatment of cancer, resulting in a growing importance in oncology. Engineered T cell therapies, namely chimeric antigen receptor (CAR) T cells and T cell receptor (TCR) T cell therapies, are platform technologies that have enabled ...

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