The S7A guideline requires the effects of all drug candidates on blood pressure, heart rate, and the electrocardiogram to be evaluated. Additionally, if warranted, further evaluation of the following endpoints may need to be studied including cardiac output, ventricular contractility, vascular resistance, the effects of endogenous and/or exogenous substances on the cardiovascular responses.
When conducting in vivo studies, the guidelines prefer use of unanesthetized animals. “Data from unrestrained animals that may be chronically instrumented for telemetry, other suitable instrumentation methods for conscious animals, or animals conditioned to the laboratory environment are preferable to data from restrained or unconditioned animals.”1
Safety pharmacology studies require the use of non-rodent species, most often primates or canines, as rats do not possess the hERG (IKr) channel. Therefore, researchers are unable to study the potential effects of a drug which may cause QT-I prolongation.
DSI solutions allow for continuous measurement of cardiovascular endpoints such as blood pressure, ECG, heart rate and more. Analysis of these endpoints can provide common biomarker information including, but not limited to, contractility, heart rate variability, and arrhythmia.