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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The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress

Journal of Pharmacological and Toxicological Methods, 2016

Colatsky T, Fermini B, Gintant G, Pierson J, Sager P, Sekino Y, ...
  • HESI - Health and Environmental Sciences Institute

The implementation of the ICH S7B and E14 guidelines has been successful in preventing the introduction of potentially torsadogenic drugs to the market, but it has also unduly constrained drug development by focusing on hERG block and QT prolongation as essential determinants of proarrhythmia risk.

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Mutagenesis Special Issue: Quantitative Genetic Toxicology (2016) This special issue was inspired by the HESI Genetic Toxicology Technical Committee’s Workshop: Genetic Toxicology at the Crossroads – From Qualitative Hazard Evaluation to Quantitative Risk Assessment

Mutagenesis, 2016

Multiple Contributors
  • HESI - Health and Environmental Sciences Institute

Applied genetic toxicology is undergoing a transition from qualitative hazard identification to quantitative dose–response analysis and risk assessment. To facilitate this change, the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) sponsored a workshop held in ...

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Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring

Therapeutic Innovation & Regulatory Science, 2016

Stewart J, Breslin WJ, Beyer BK, Chadwick K, De Schaepdrijver L, ...
  • HESI - Health and Environmental Sciences Institute

The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials.

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Micro-CT Imaging: Developing Criteria for Examining Fetal Skeletons in Regulatory Developmental Toxicology Studies – A Workshop Report

Regulatory Toxicology and Pharmacology, 2016

Solomon HM, Makris SL, Alsaid H, Bermudez O, Beyer BK, Chen A, ...
  • HESI - Health and Environmental Sciences Institute

During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies.

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HESI/FDA Workshop on Immunomodulators and Cancer Risk Assessment: Building Blocks for a Weight-of-Evidence Approach

Regulatory Toxicology and Pharmocology, 2015

Lebrec H, Brennan FR, Haggerty H, Herzyk D, Kamperschroer C, ...

Profound immunosuppression (e.g., AIDS, transplant therapy) is epidemiologically associated with an increased cancer risk, and often with oncogenic viruses. It is currently unclear how broadly this association translates to therapeutics that modulate immunity. A workshop co-sponsored by the FDA and HESI examined how ...

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Health and Environmental Sciences Institute (HESI)

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