SAFETY PHARMACOLOGY

Abstract

Safety pharmacology is the evaluation and study of the potentially life-threatening pharmacologic effects of a potential drug which is unrelated to the desired therapeutic effect, and therefore may present a hazard–particularly in individuals who already have one or more compromised or limited organ system functions. The cardiovascular system is one of the primary vital functions which must be examined during safety pharmacology studies. The primary screening tool for central nervous system safety pharmacology evaluation is the functional observational screen, which seeks to use objective but noninvasive methods for evaluating the pharmacologic effects of a drug on peripheral and nervous system effects. The known effects of drugs from a variety of pharmacologic/therapeutic classes on the respiratory system and worldwide regulatory requirements support the need for conducting respiratory evaluations in safety pharmacology. The kidneys are an important target for toxic effects of drug candidates.