Safety of candidate drugs is critical when entering clinical test phases. As part of our preclinical drug development services, we offer strategic Safety Pharmacology testing, both as stand-alone studies or as part of an integrated package with other initial safety studies.
Core test battery according to current ICH guidelines:
Cardiovascular system: in-vivo telemetry in dogs or minipigs, hERG assay
Central nervous system: functional observations, motor activity assessment in rats
Respiratory system: respiratory function in dogs, rats or guinea pigs.
In addition to the core battery of safety studies, a wide variety of follow-up and supplemental study designs for advanced testing of possible adverse effects on vital functions is available, including:
Central Nervous System: anesthesia, analgesia, convulsive activity, learning and memory, startle reflex, EEG, advanced neuropathology