Maronpot Robert R, Nyska Abraham, Troth Sean P, Gabrielson Kathleen, Sysa-Shah Polina, Kalchenko Vyacheslav, Kuznetsov Yuri, Harmelin Alon, Schiffenbauer Yael S, Bonnel David, Stauber Jonathan, Ramot Yuval
1 Maronpot Consulting LLC, Raleigh, North Carolina, USA.
2 Toxicologic Pathology, Sackler School of Medicine, Tel Aviv University, Timrat, Israel.
Toxicol Pathol. 2017 Jun;45(4):444-471. doi: 10.1177/0192623317710014.
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.
可用于临床前毒理学研究的成像系统越来越多地显示出其作为毒理病理学家工具库中重要工具的效用，能够对组织中的功能和形态变化进行纵向评估，并提供诸如器官和病变体积等传统毒理学研究参数无法获得的重要信息。本文介绍了超声、正电子发射断层扫描/单光子发射计算机断层扫描、光学、磁共振成像以及基质辅助激光解吸电离-成像质谱成像等在毒理学研究和临床前研究中的实际成像应用的代表性实例。还介绍了使成像系统符合用于监管申报的良好实验室规范所面临的一些挑战。鼓励在监管申报中将成像数据逐案用作安全性评估的一部分。
