Cardiovascular Safety Pharmacology Studies
Cardiovascular Safety Pharmacology Studiesin Conscious Dogs and Nonhuman Primates
The assessment of cardiovascular function (electrocardiogram (ECG), heart rate and blood pressure) in a non-rodent species is obligatory prior to starting Phase I human clinical trials for all new chemical entities thus necessitating cardiovascular safety pharmacology studies.
The main focus of cardiovascular safety pharmacology studies is to evaluate drug-induced prolongation of the QT interval due to an impairment in ventricular repolarization. Drugs that prolong the QT interval are associated with torsades de pointes (TdP), a life-threatening arrhythmia.
The vast majority of drugs that can cause QT prolongation inhibit hERG channels, therefore current regulatory guidelines concerning cardiac safety recommend that all compounds are subject to in vitro evaluation of hERG blocking and to in vivo assessment of QT interval prolongation in an appropriate animal model and in humans.
In the case of in vivo studies, ICH S7A and S7B guidelines recommend the use of conscious, unrestrained animals using telemetry devices to capture data, as these assay conditions are more “physiological” and resemble the clinical setting.
Vivotecnia offers in-house colonies of telemetry-implanted animals for fast start-up cardiovascular safety pharmacology studies.
Our telemetry system provider, DSI, is the recognized leader in physiologic monitoring offering telemetry, instrumentation, software and services in support of research.
Hardware and software technology
- DSI PhysioTel Digital (PTD) System (Data Sciences International, Minnesota, USA):
- CFR 21 Part 58 (GLP) and CFR 21 Part 11 compliant
- Digitally encoded data (device ID and serial number, battery status and battery “ON” time)
Implantable telemetry (DSI)
- Freely moving animals (eliminate restraint stress = refinement)
- Reduced number of animals
- High-quality data – accuracy and reliability
- Measurements can be made with no lab personnel present