Safety Pharmacology (US)

Overview

Safety pharmacology studies are designed to investigate the 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, gastrointestinal and immune functions may also be performed. The following types of safety pharmacology studies, in both large and small animals, are performed in our US facilities:

Core Battery Tests

Central Nervous System (Rodents)

• Coordination, sensory/motor responses

• Functional observation battery (Modified Irwin Screen)

• Locomotor activity

• Rotorod

Cardiovascular System - Telemetry (Canines, Monkeys, Pigs)

• Activity

• Blood pressure (SAP, DAP and MAP)

• Body temperature

• Electrocardiogram (QT/QTc)

• Heart rate

Respiratory System

• Capnography (SpO2, ETCO2) (Canines, Monkeys)

• Respiratory rate (Canines, Monkeys)

• Plethysmography (Rats, Canines, Monkeys)

Supplemental Battery Tests

Central Nervous System (Rodents)

• Analgesia test (Tail Flick)

• Learning and memory

• Startle response

Renal/Urinary System Urinalysis (Canines, Monkeys)

• Cytology

• Fluid/electrolyte balance

• GFR (creatinine clearance)

• Osmolarity

• pH

• Proteins

• Specific gravity

• Volume

Gastrointestinal System - Transit Time

• Gastric motility and transit