Regulatory Forum Opinion Piece∗: Imaging Applications in Toxicologic Pathology-Recommendations for Use in Regulated Nonclinical Toxicity Studies

Robert R. Maronpot, Abraham Nyska, Sean P. Troth, Kathleen Gabrielson, Polina Sysa-Shah, Vyacheslav Kalchenko, Yuri Kuznetsov, Alon Harmelin, Yael S. Schiffenbauer, David Bonnel, Jonathan Stauber, Yuval Ramot

Research output: Contribution to journalArticlepeer-review

Abstract

Available imaging systems for use in preclinical toxicology studies increasingly show utility as important tools in the toxicologic pathologist's armamentarium, permit longitudinal evaluation of functional and morphological changes in tissues, and provide important information such as organ and lesion volume not obtained by conventional toxicology study parameters. Representative examples of practical imaging applications in toxicology research and preclinical studies are presented for ultrasound, positron emission tomography/single-photon emission computed tomography, optical, magnetic resonance imaging, and matrix-assisted laser desorption ionization-imaging mass spectrometry imaging. Some of the challenges for making imaging systems good laboratory practice-compliant for regulatory submission are presented. Use of imaging data on a case-by-case basis as part of safety evaluation in regulatory submissions is encouraged.

Original languageEnglish (US)
Pages (from-to)444-471
Number of pages28
JournalToxicologic pathology
Volume45
Issue number4
DOIs
StatePublished - Jun 1 2017

Keywords

  • CT
  • MALDI imaging
  • MRI
  • PET
  • optical imaging
  • preclinical imaging
  • toxicologic pathology
  • ultrasound imaging

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Biology
  • Toxicology
  • Cell Biology

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