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- Title
Characterizing “Adversity” of Pathology Findings in Nonclinical Toxicity Studies.
- Authors
Palazzi, Xavier; Burkhardt, John E.; Caplain, Henri; Dellarco, Vicki; Fant, Pierluigi; Foster, John R.; Francke, Sabine; Germann, Paul; Gröters, Sibylle; Harada, Takanori; Harleman, Johannes; Inui, Kosei; Kaufmann, Wolfgang; Lenz, Barbara; Nagai, Hirofumi; Pohlmeyer-Esch, Gabriele; Schulte, Agnes; Skydsgaard, Mikala; Tomlinson, Lindsay; Wood, Charles E.
- Abstract
The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports, to serve as a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP.
- Subjects
DRUGS; PATHOLOGY; PREVENTIVE medicine; MEDICINE; DIAGNOSIS
- Publication
Toxicologic Pathology, 2016, Vol 44, Issue 6, p810
- ISSN
0192-6233
- Publication type
Article
- DOI
10.1177/0192623316642527