ABSTRACT
Clinical pathology is a standard element of nonclinical safety assessment studies and typically consists of routine hematology, coagulation, clinical chemistry, and urinalysis tests. Test results provide a broad screen of important tissues and organ systems, metabolic functions, and pathophysiologic responses. Test article-related effects on these results help identify target organs, establish dose responses, corroborate other study ndings, assess severity of toxic effects, and quantify certain pharmacodynamic effects. Clinical pathology ndings also serve to meet regulatory needs and, most importantly, provide clinicians with important monitoring information prior to clinical trials.
