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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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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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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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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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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‘All In’: A Pragmatic Framework for COVID‐19 Testing and Action on a Global Scale

EMBO Molecular Medicine, 2020

Pettit SD, Jerome KR, Rouquie D, Mari B, Barbry P, Kanda Y, ...
  • HESI - Health and Environmental Sciences Institute

Current demand for SARS‐CoV‐2 testing is straining material resource and labor capacity around the globe. As a result, the public health and clinical community are hindered in their ability to monitor and contain the spread of COVID‐19. Despite broad consensus that more testing is needed, pragmatic guidance towards ...

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Ontogeny and Cross-Species Comparison of Pathways Involved in Drug Absorption, Distribution, Metabolism, and Excretion in Neonates (Review): Kidney

Drug Metabolism and Disposition, 2020

Bueters R, Bael A, Gasthuys E, Chen C, Schreuder MF, Frazier KS
  • HESI - Health and Environmental Sciences Institute

This review provides insight in cross-species developmental differences of absorption, distribution, metabolism, and excretion properties in the kidney, which should be considered in neonate/juvenile study interpretation, hypotheses generation, and experimental design.

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