Pandiri Arun R, Kerlin Roy L, Mann Peter C, Everds Nancy E, Sharma Alok K, Myers L Peyton, Steinbach Thomas J
1 National Toxicology Program, Research Triangle Park, North Carolina, USA.
2 Drug Safety Research and Development, Pfizer Inc., Groton, Connecticut, USA.
Toxicol Pathol. 2017 Jan;45(1):238-247. doi: 10.1177/0192623316672352. Epub 2016 Oct 23.
One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course.
毒理病理学家面临的主要挑战之一是确定并区分真正的不良反应与非不良反应或适应性反应。毒理病理学会（STP）和欧洲毒理病理学会最近发表的文章为非临床毒理学研究中确定和传达不良反应提供了指导。为了提供一个就这一重要话题进行交流和讨论的平台，2016年在加利福尼亚州圣地亚哥举行的STP年会上举办了一场继续教育（CE）课程。该课程的讲座通过涉及临床病理学和解剖病理学的案例研究，为确定和传达不良反应提供了指导。此外，有一场讲座还聚焦于数据质量、研究设计以及可能妨碍确定不良反应的假象的解读。CE课程最后是一场关于理解临床前研究中的不良反应以及让监管机构参与决策过程的讲座。本文旨在对这一广受欢迎的CE课程中的所有讲座进行简要总结。
