Chapter 13 - Preparation of the Anatomic Pathology Report for Toxicity Studies

• Published in: Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2: Safety Assessment and Toxicologic Pathology pp. 495 - 504
• Main Authors: Donnelly, Kevin B., Guffroy, Magali R.
• Format: Book Chapter
• Language: English
• Published: Elsevier Inc 2023
• Edition: Fourth Edition
• Subjects: Concise description; NOAEL; Pathology report; Target organ; Test article related; Text table; Pathology report; Concise description; NOAEL; Target organ; Test article related; Text table
• ISBN: 9780323910521; 0128210478; 9780128210475; 0323910521
• DOI: 10.1016/B978-0-12-821047-5.00009-9

The results presented in the anatomic pathology report are significant to the interpretation of a test article or device's toxicity for an audience that includes scientific colleagues and collaborators, and regulatory reviewers. Development of an anatomic pathology report begins with understanding the study protocol, followed by careful evaluation of the total available study data. Documentation of findings must use formats that are predetermined and orderly. A peer review of the microscopic data provides a quality check. The written report should include a concise narrative and summary tables that can be readily understood and can be incorporated into the final toxicity study report. Because of the volume of postmortem information and various formats used by test-site facilities, the pathologist must distill significant findings into text tables and use a concise narrative to provide the audience with a report that includes identification of the target organs, the nature and significance of the findings, their relationship to dose or exposure, their relationship to changes noted in other parameters assessed in the study, the reversibility of the findings, and their contribution to the determination of a no-observed-adverse-effect level (NOAEL). A poorly written report leaves questions in the reader(s) mind, may require significant effort to clarify, may perpetuate inaccuracies, and could lead to a lengthened review period by regulatory agency reviewers.