Safety Pharmacology
Safety pharmacology studies are designed to investigate effects of test articles on vital functions in mammalian species. Primary evaluations include cardiovascular, respiratory, and central nervous system assessment. Supplemental evaluations of renal/urinary function, gastrointestinal function, and immune function may also be performed. The following types of safety pharmacology studies, in both large and small animal species, are conducted in compliance with GLP regulations, specifically stand-alone or combined and/or incorporated with toxicology studies:
Core Battery Tests
Central Nervous System (Rodents)
- Functional observation battery (FOB - rodents)
- Locomotor activity (rodents, canines and NHPs)
- EEG evaluation (rodents and NHPs)
Cardiovascular System
Radiotelemetry (Rats, Guinea Pigs, Canines, Non-Human Primates)
- Blood pressure
- Body temperature
- Electrocardiogram (QT/QTc)
Noninvasive cardiovascular assessments in conscious large animals
- ECG: Multi-leads/Lead II ECGs
- Blood pressure: High Definition Oscillometry (HDO)
In vitro cardiovascular evaluation
- hERG screening in stably transfected HEK293 cells and other cell lines (non-GLP in service, GLP under validation)
- Potassium Channel recordings in heart muscle cell and Purkinje fiber for APD90 and/or MAP measurements (under validation)
Respiratory System (Canines, Non-Human Primates)
- Tide volume
- Respiratory rate
- Minute volume
Additional Safey Pharmacology Models
- Renal/Urinary System, Gastrointestinal System, Seizure models, Electromyography, Abuse liability etc.
- Several follow-up/investigative models