Cardiovascular Safety Pharmacology Studies
in Conscious Dogs and Non-Human Primates
The assessment of cardiovascular function (electrocardiogram (ECG), heart rate and blood pressure) within a non-rodent species is a requirement prior to the start of Phase I human clinical trials for all new chemical entities.
The main focus of cardiovascular safety pharmacology studies is to assess drug-induced prolongation in the QT interval due to an impairment of the 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 an in vitro evaluation of hERG block together with assessment of in vivo 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, since these assays 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 by offering telemetry, instrumentation, and software and services in support of research. Check out our telemetry system here: Link
Hardware and Software technology
- DSI PhysioTel Digital (PTD) System (Data Sciences International; Minesota, USA):
- CFR 21 Part 58 (GLP) and CFR 21 Part 11 compliant
- Digital encoded data (device ID and serial number, battery status and battery “ON” time)
Implantable telemetry (DSI)
- Freely moving animals (eliminate restraining stress – refinement)
- Reduction in the number of animals
- High data quality –accuracy and reliability–
- Measurements can be obtained with no lab personnel present
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