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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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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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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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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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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Enhancing quality of life as a goal for anticancer therapeutics

Science Translational Medicine, 2016

Syril D. Pettit, Steven E. Lipshultz, Charles S. Cleeland, ...
  • HESI - Health and Environmental Sciences Institute

Advances in cancer therapy has resulted in more cancer survivors, and now quality of life throughout treatment and surviving years is becoming a new focus for the scientific community. There are often unintended toxicities related to cancer therapies. HESI established the THRIVE program to address quality-of-life research.

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