Considerations for the Identification and Conveyance of Clinical Pathology Findings in Preclinical Toxicity Studies: Results From the 9th ESTP International Expert Workshop.
Tara Arndt, Monika Keresztes, Blanck Olivier, L. Boone, Franck Chanut, D. Ennulat, Ellen Evans, Alexius Freyberger, S. Johannes, C. F. Kuper, P. Maliver, Peter O'Brien, L. Ramaiah, Ian Roman, Volker Strauss, Petra Vinken, Dana Walker, Michael Winter, G. Pohlmeyer-Esch, Lindsay Tomlinson
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引用次数: 0
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.
期刊介绍:
Toxicologic Pathology is dedicated to the promotion of human, animal, and environmental health through the dissemination of knowledge, techniques, and guidelines to enhance the understanding and practice of toxicologic pathology. Toxicologic Pathology, the official journal of the Society of Toxicologic Pathology, will publish Original Research Articles, Symposium Articles, Review Articles, Meeting Reports, New Techniques, and Position Papers that are relevant to toxicologic pathology.