Prior to phase I clinical trials, the effects of a therapeutic on the cardiovascular (CV) system, which is a vital organ system, should be evaluated and characterized. The Attentive Science safety pharmacologist combines his/her knowledge from Physiology, Pharmacology and Toxicology to evaluate effects on the electrocardiogram (ECG), with particular emphasis on ventricular depolarization and repolarization, as well as any potential effects on blood pressure (BP) and heart rate (HR). The effect of a test substance on BP and HR is an important consideration in a benefit/risk analysis.
Focusing on In-vivo evaluation and using the intended clinical dose route, one needs to pay particular attention to the cardiovascular system. By determining the safety margin as well as performing a risk/benefit analysis in a dedicated study, you will then be able to provide safety assurance within your program as well as to your intended population.