Integrated safety pharmacology studies for cardiovascular, CNS, and respiratory systems
Regulatory submissions such as IND filings are considered incomplete without robust safety pharmacology data addressing these critical functions. 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
