Calvert Holdings

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Telemetry

With the issuance of the ICH S7A guidelines for safety pharmacology in July 2001 came the preference for the use of unanesthetized animals when evaluating the safety profile of new pharmaceutical agents. When examining the safety of these compounds on the cardiovascular system, the parameters of interest include blood pressure (BP), heart rate (HR) and electrocardiogram (ECG). Classical methods of obtaining measurements from conscious animals required the use of either a tether or restraining device with measurements taken by indwelling exteriorized catheters, vascular access ports or BP cuffs. While these methods allowed for monitoring of conscious animals, they also allowed for the potential of infection, problems with patency and stress artifacts that could affect the data being obtained.

Telemetry provides a means of obtaining measurements of physiological functions in conscious animals without the problems associated with the classical methods. It allows for total freedom of the animal to move about its home environment, eliminates potential pathways for infectious agents to enter the body, and provides the ability to take measurements around the clock without human interaction that could cause additional stress to the animal. Telemetry involves two main components, a transmitter and a receiver. The transmitter is fully implanted in the abdominal cavity while the receiver detects the radio waves transmitted from the animal and passes the signal to a computer which records the data.

Calvert purchased the Integrated Telemetry Systems (ITS) package in 1999 and began performing GLP studies on implanted dogs from our telemetry colony on the fully validated system in 2000. A non-human primate colony was established in 2004. The pharmacology department can perform these studies for our clients as part of the core battery of safety pharmacology studies required by the ICH guidelines. They can also be performed earlier in development for help in making key decisions such as early detection of cardiac risks.