Principles of Toxicologic Clinical Pathology

Abstract

Clinical pathology is an important aspect of safety testing in nonclinical toxicology studies. Standard analyses include hematology, coagulation, clinical chemistry, and urinalysis testing. The results of these evaluations help corroborate clinical observations and histopathologic findings, provide insight into the No-observed Adverse Effect Level (NOAEL), characterize the monitorability of test article-related changes, and, in some instances, provide translational biomarkers for human clinical studies. Because data can be collected throughout the course of a study, the temporal relationship of test article-related findings can also be elucidated. It is critical to understand the relationship between clinical pathology test results and findings obtained from microscopic pathology evaluations. The differences between clinical and anatomic pathology may at first seem considerable but fundamentally are nothing more than using different testing modalities to conduct evaluations on the same organ systems.