Integrated safety pharmacology studies for cardiovascular, CNS, and respiratory systems
Safety pharmacology data support the nonclinical evaluation of drug candidates and form an important component of regulatory submission packages, including IND applications. Aragen Biosafety Solutions offers an integrated approach to GLP-regulatory safety pharmacology and non-GLP discovery pharmacology testing performed in compliance with the ICH S7A and S7B guidelines.
Cardiovascular
- hERG potassium channel inhibition assay (patch clamp)
- In vivo cardiovascular assessments in telemetered dogs and non-human primates
CNS
- Functional observational battery (FOB) and modified Irwin’s test
- Assessment of motor activity, behavioral changes, coordination, and sensory/motor reflexes
- Neurotoxicity evaluations
Respiratory
- Measurement of respiratory rate and frequency
- Tidal and minute volume assessment
- Hemoglobin oxygen saturation (Hb-O₂)
- Blood gas and blood pH analysis
Gastrointestinal
- Gastric motility and functional assessments
- Intestinal transit time evaluation
- Gastric secretion studies
