ABSTRACT

Clinical pathology is an integral component of nonclinical safety assessment and toxicology studies designed to identify target organ toxicity and establish dose-response relationships. In the context of these studies, clinical pathology usually consists of relatively routine hematology, clinical chemistry, and urinalysis tests. The majority of parameters evaluated are identical to those used in human and veterinary medicine because the fundamental physiology and pathophysiology of blood and major organ systems are similar in most species used in toxicology studies. There are, of course, species differences for reference intervals, some methodologies, the value or appropriateness of individual tests, and interpretation of •ndings. Selection of tests for a toxicology study is dependent on several factors, including study objectives, test species, regulatory requirements, and test article characteristics.