Considerations for the Identification and Conveyance of Clinical Pathology Findings in Preclinical Toxicity Studies: Results From the 9th ESTP International Expert Workshop
Toxicol Pathol. 2024 Apr 25:1926233241245108. doi: 10.1177/01926233241245108. Online ahead of print.ABSTRACTThe 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.PMID:38661116 | DOI:10.1177/01926233241245108
Source: Toxicologic Pathology - Category: Pathology Authors: Tara Arndt Monika Keresztes Blanck Olivier L Boone Franck Chanut D Ennulat Ellen Evans Alexius Freyberger S Johannes C Frieke Kuper Pierre Maliver Peter O'Brien Lila Ramaiah Ian Roman Volker Strauss Petra Vinken Dana Walker Michael Winter Gabriele Pohlmey Source Type: research