Crabbs Torrie A, McDorman Kevin S
1 Experimental Pathology Laboratories, Inc., Research Triangle Park, North Carolina, USA.
2 Charles River Laboratories, Inc., Frederick, Maryland, USA.
Toxicol Pathol. 2018 Dec;46(8):920-924. doi: 10.1177/0192623318798758. Epub 2018 Sep 6.
This article provides a synopsis of the first two presentations from the second scientific session of the 37th Annual Symposium of the Society of Toxicologic Pathology in Indianapolis, Indiana, on June 18, 2018; the session focused on acute kidney injury. The first presentation, given by Dr. Kevin McDorman, focused on "Fundamentals of Renal Tubule and Interstitial Anatomy and Physiology." Several common background findings from toxicity studies were additionally discussed. Lastly, factors that impact the relevance and usefulness of historical control data, such as quality and consistency of histopathology, were discussed. The second presentation, given by Dr. Torrie Crabbs, provided a review of International Harmonization of Nomenclature and Diagnostic Criteria (INHAND), Standard for Exchange of Nonclinical Data (SEND), and drug-induced kidney injury (DIKI) nomenclature. INHAND is a global collaborative project that provides internationally accepted standardized nomenclature and diagnostic criteria for proliferative and nonproliferative changes in laboratory animals in toxicity and carcinogenicity studies. SEND is currently a required standard for data submission to the Food and Drug Administration (FDA). Since the FDA has indicated its preference for INHAND nomenclature, SEND will predominately use INHAND terminology; thus, familiarity with INHAND terminology is critical for toxicologic pathologists. The diagnostic features of three common DIKI findings, in addition to several complicated INHAND terminologies, were reviewed.
本文概述了2018年6月18日在印第安纳州印第安纳波利斯市举行的毒理病理学会第37届年会第二次科学会议的前两场报告;该会议聚焦于急性肾损伤。第一场报告由凯文·麦克多曼博士主讲,重点是“肾小管和间质解剖学与生理学基础”。此外,还讨论了毒性研究中的一些常见背景发现。最后,探讨了影响历史对照数据相关性和实用性的因素,如组织病理学的质量和一致性。第二场报告由托里·克拉布斯博士主讲,回顾了国际命名和诊断标准协调(INHAND)、非临床数据交换标准(SEND)以及药物性肾损伤(DIKI)命名法。INHAND是一个全球合作项目,为毒性和致癌性研究中实验动物的增殖性和非增殖性变化提供国际认可的标准化命名和诊断标准。SEND目前是向美国食品药品监督管理局(FDA)提交数据的一项必需标准。由于FDA已表明倾向于使用INHAND命名法,SEND将主要采用INHAND术语;因此,熟悉INHAND术语对毒理病理学家至关重要。除了几个复杂的INHAND术语外,还回顾了三种常见DIKI发现的诊断特征。