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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Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

Drug Metabolism and Disposition, 2019

Neal-Kluever A, Fisher J, Grylack L, Kakiuchi-Kiyota S, ...

This review is part of a multisector collaborative research effort coordinated by the HESI Developmental and Reproductive Toxicology (DART) Committee to increase the knowledge base in the nonclinical neonatal space to better inform clinical treatment decisions made for the newborn patient population (De Schaepdrijver et ...

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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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PBPK Model Reporting Template for Chemical Risk Assessment Applications

Regulatory Toxicology and Pharmacology, 2020

Tan YM, Chan M, Chukwudebe A, Domoradzki J, Fisher J, Hack CE, ...
  • HESI - Health and Environmental Sciences Institute

Physiologically-based pharmacokinetic (PBPK) modeling analysis does not stand on its own for regulatory purposes but is a robust tool to support drug/chemical safety assessment. While the development of PBPK models have grown steadily since their emergence, only a handful of models have been accepted to support regulatory ...

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