Basic safety pharmacology: the cardiovascular system

Abstract

The cardiovascular system is one of the primary vital functions which have to be examined during safety pharmacology studies. Cardiovascular system functioning is maintained by cardiac electrical activity and by pump-muscle function which contribute to haemodynamic efficacy. The aim of cardiovascular safety pharmacology is to evaluate the effects of test substances on the most pertinent components of this system, in order to detect potentially undesirable effects, before engaging in clinical trials. In the basic programme, a detailed haemodynamic evaluation is carried out in the anaesthetized dog. It is completed by cardiac and/or cellular electrophysiology investigations in order to assess the arrhythmogenic risk. The basic programme can be preceded by rapid and simple testing procedures, during the early drug discovery stage. It should be completed, if necessary, by specific supplementary studies, depending on the data obtained during the early clinical trials. The following article describes and presents an analytic strategy aimed at problems of cardiovascular risk.