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

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

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

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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The COMPARE Database: A Public Resource for Allergen Identification, Adapted for Continuous Improvement

The availability of databases identifying allergenic proteins via a transparent and consensus-based scientific approach is of prime importance to support the safety review of genetically-modified foods and feeds, and public safety in general. Over recent years, screening for potential new allergens sequences has become ...

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Investigating Endocrine Disrupting Properties of Chemicals in Fish and Amphibians: Opportunities to Apply the 3Rs

Many regulations are beginning to explicitly require investigation of a chemical's endocrine disrupting properties as a part of the safety assessment process, for substances already on or about to be placed on the market. Different jurisdictions are applying distinct approaches. However, all share a common theme requiring ...

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Permitted Daily Exposure Limits for Noteworthy N-Nitrosamines

A genotoxic carcinogen, N-nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs in 2018, and other N-nitrosamines, such as N-nitrosodiethylamine (NDEA), were later detected in other sartan products. N-nitrosamines are pro-mutagens that can react with DNA following metabolism to produce ...

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Health and Environmental Sciences Institute (HESI)

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