Abstract
This validation study was undertaken to demonstrate the ability of the DSI Telemetry system to detect physiological changes induced by test items of known pharmacological activity in the Beagle dog. For this purpose 4 adult Beagle dogs were surgically implanted with DSI TL11 M2-D70-PCT radio-telemetry devices. Following at least 3 weeks recovery from surgery the animals were assigned to the validation which comprised of 3 phases. Phase 1- Sotalol given orally at doses of 0, 4, 8 and 16 mg/kg. Phase 2 - Nifedipine given orally at doses of 0, 1, 2.5 and 5 mg/kg. Phase 3 – Cisapride given orally at doses of 0, 2, 4 and 8 mg/kg. All doses were administered at 1 to 2 day intervals. Systolic, diastolic and mean arterial blood pressure(MAP) , heart rate , Lead II ECG variables (PR, QT, QTcV and RR interval and QRS duration) and core body temperature were measured continuously for 1h prior to dosing and for up to 6h post dose. The animals were monitored for the recording period by digital CCTV. Data acquisition and analysis were performed using the Notochord HEM 3.5/DSI OpenART 2.3 system. Sotalol and Cisapride both produced dose dependent increases in QTcV. Nifedipine produced a dose dependent increase in heart rate and reduction in MAP. The Inveresk dog telemetry set up provides a scientifically robust system for conducting GLP studies.
