Safety Pharmacology Studies

Cardiovascular, CNS, respiratory, gastrointestinal and renal IND filings are incomplete without the inclusion of safety pharmacology tests that assess the impact on the body’s major physiological systems like cardiovascular, respiratory, and central nervous system behavior. Intox 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 patch clamp assay
• Studies in telemetered dogs and non-human primates

CNS

• Motor activity, behavioral changes, coordination, sensory/motor reflex responses, temperature (e.g., FOB, modified Irwin’s test, Neurotoxicity testing)

Respiratory

• Respiratory rate, Hb-O2 saturation, frequency, tidal & minute volume, blood gas, blood pH

Gastrointestinal

• Gastric motility and function, intestinal transit time, gastric secretion