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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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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The Gut Microbiome and Xenobiotics: Identifying Knowledge Gaps

Toxicological Sciences, 2020

Sutherland VL, McQueen CA, Mendrick D, Gulezian D, Cerniglia C, ...
  • HESI - Health and Environmental Sciences Institute

There is an increasing awareness that the gut microbiome plays a critical role in human health and disease, but mechanistic insights are often lacking. In June 2018, HESI held a workshop, “The Gut Microbiome: Markers of Human Health, Drug Efficacy and Xenobiotic Toxicity” to identify data gaps in determining how gut ...

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Echocardiographic and Hemodynamic Indices of Myocardial Contractility Simultaneously Evaluated in Telemetered Beagle Dogs: A HESI-Sponsored Cross-Company Evaluation

Journal of Pharmacological and Toxicological Methods, 2020

Rossman EI, Cools F, Cordes J, Dhuyvetter D, Doyle JM, ...
  • HESI - Health and Environmental Sciences Institute

Alterations in cardiac contractility can have significant clinical implications, highlighting the need for early detection of potential liabilities. Pre-clinical methods to assess contractility are typically invasive and their translation to human measures of cardiac function are not well defined. Clinically, cardiac ...

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Approaches to Dose Finding in Neonates, Illustrating the Variability Between Neonatal Drug Development Programs

Pharmaceutics, 2020

Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, ...
  • HESI - Health and Environmental Sciences Institute

Drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. It is critically important that all sources of information be leveraged to optimize dose selection for ...

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Improving the Environmental Risk Assessment of Substances of Unknown or Variable Composition, Complex Reaction Products, or Biological Materials (UVCBs)

Environmental Toxicology and Chemistry, 2020

Salvito D, Fernandez M, Jenner K, Lyon DY, de Knecht J, Mayer P, ...
  • HESI - Health and Environmental Sciences Institute

Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs) pose unique risk assessment challenges to regulators and to product registrants. These substances can contain many constituents, sometimes partially unknown and/or variable, depending on fluctuations in their ...

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Development of the First Reference Antibody Panel for Qualification and Validation of Cytokine Release Assay Platforms: Report of an International Collaborative Study

Cytokine, 2020

Vessillier S, Fort M, O'Donnell L, Hinton H, Nadwodny K, ...

Author links open overlay Immunomodulatory therapeutics such as monoclonal antibodies (mAb) carry an inherent risk of undesired immune reactions. One such risk is cytokine release syndrome (CRS), a rapid systemic inflammatory response characterized by the secretion of pro-inflammatory cytokines from immune cells. It is ...

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