Safety Pharmacology: Introduction

Abstract

The adverse effects of new drug entities in animals and humans can be manifested by changes in the structural, biochemical, or physiological status of the organism. In the preclinical safety assessment process, toxicological procedures have traditionally focused on the structural and biochemical consequences of drug actions. As a result, there has been a reliance on histopathological evaluation of organs and clinical pathology measures in the toxicological assessment of new drug candidates. Physiological or functional observations of drug action were mostly conducted outside of the safety assessment processes. The last decade has seen a growing awareness of the importance of physiological measures of drug toxicity. This awareness has been prompted by clinical issues of life-threatening effects, e.g., cardiovascular functions. These issues have prompted regulatory action and involvement with respect to “safety pharmacology.”