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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Comparisons of PNEC Derivation Logic Flows Under Example Regulatory Schemes and Implications for ecoTTC

Regulatory Toxicology and Pharmacology, 2021

Belanger SE, Beasley A, Brill JL, Krailler J, Connors KA, Carr GJ, ...

Derivation of Predicted No Effect Concentrations (PNECs) for aquatic systems is the primary deterministic form of hazard extrapolation used in environmental risk assessment. Depending on the data availability, different regulatory jurisdictions apply application factors (AFs) to the most sensitive measured endpoint to ...

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Methodological Considerations for Measuring Biofluid-Based MicroRNA Biomarkers

Critical Reviews in Toxicology, 2021

Chorley BN, Atabakhsh E, Doran G, Gautier JC, ...

MicroRNAs (miRNAs) are small non-coding RNA that regulate the expression of messenger RNA and are implicated in almost all cellular processes. Importantly, miRNAs can be released extracellularly and are stable in these matrices where they may serve as indicators of organ or cell-specific toxicity, disease, and biological ...

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Permitted Daily Exposure Limits for Noteworthy N-Nitrosamines

Environmental and Molecular Mutagenesis, 2021

Johnson GE, Dobo K, Gollapudi B, Harvey J, Kenny J, Kenyon M, ...

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

Integrated Environmental Assessment and Management, 2021

Burden N, Embry MR, Hutchinson TH, Lynn SG, Maynard SK, ...

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

Frontiers in Allergy, 2021

van Ree R, Ballerda DS, Berin MC, Beuf L, Chang A, Gadermaier G, ...

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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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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