Abstract：
The European Society of Toxicologic Pathology (ESTP) organized a panel of 24 international experts from many fields of toxicologic clinical pathology (e.g., industry, academia, and regulatory) that came together in 2021 to align the use of terminology to convey the importance of clinical pathology findings in preclinical toxicity studies. An additional goal consisted of how to identify important findings in standard and nonstandard clinical pathology associated endpoints. This manuscript summarizes the information and opinions discussed and shared at the ninth ESTP International Expert Workshop, April 5 to 6, 2022. In addition to terminology usage, the workshop considered topics related to the identification and conveyance of the importance of test item-related findings. These topics included sources of variability, comparators, statistics, reporting, correlations to other study data, nonstandard biomarkers, indirect/secondary findings, and an overall weight-of-evidence approach.
摘要：
欧洲毒理学病理学会（ESTP）组织了一个由来自毒理学临床病理学许多领域的24名国际专家组成的小组（例如，工业,学术界,和监管）于2021年聚集在一起，以协调术语的使用，以传达临床病理学发现在临床前毒性研究中的重要性。另一个目标是如何确定标准和非标准临床病理学相关终点的重要发现。本手稿总结了第九届ESTP国际专家研讨会上讨论和分享的信息和意见，2022年4月5日至6日。除了术语用法，研讨会审议了与确定和传达测试项目相关发现重要性有关的主题。这些主题包括变异性的来源，比较器,统计数据，reporting,与其他研究数据的相关性，非标准生物标志物，间接/次要发现，和总体证据权重方法。
