ABSTRACT
Safety pharmacology studies are performed to help in the prediction of potential pharmacological adverse effects on physiological functions of new chemical entities (NCEs) and biotechnology-derived products prior to ¢rst administration to man (ICH S7A, 2001). Therefore, safety pharmacology studies are designed to investigate functional effect as opposed to morphological changes (toxicology) induced by an NCE. The main objectives of these studies are: (1) to identify undesirable pharmacodynamic properties of a substance that may have relevance to its human safety; (2) to evaluate adverse pharmacodynamic and/or pathophysiological effects of a substance observed in toxicology and/or clinical studies; and (3) to investigate the mechanism of the adverse pharmacodynamic effects observed and/or suspected. These objectives have been primarily driven by the necessity of protecting the individuals (volunteers or patients) who are participating in clinical trials as well as the patients receiving marketed drugs.
