SAFETY PHARMACOLOGY

TRL has fully validated test systems for evaluation fo safety pharmacology studies to support regulatory requirements, including ICH S7A and S7B. TRL offers a range of animals species for completing the required battery of safety pharmacology studies, including rats, dogs, and non-human primates. 

An experienced in-house team surgically implant the telemetry transmitters prior to study initiation.  State of the art telemetry equipment is utilized for monitoring of freely moving, conscious animals.  These systems were validated using positive control agents effecting parameters such as QT-prolongation. 

In addition, TRL has the DSI jacketed external telemetry (JET) system.  This system allows monitoring of freely moving large animals without invasive surgical procedures. 

The core battery of testing validated at TRL includes:

• Cardiovascular Testing in dogs and non-human primates
• Central nervous system
• Respiratory System
• Functional Observational Battery