Overview

Safety pharmacology studies are designed to investigate the potential for adverse pharmacological events.  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 facilities in compliance with tripartite harmonized guidelines.

 

Core Battery Tests

Central Nervous System (Rodents)

• Coordination, Sensory/Motor Responses

• Functional Observational Battery (FOB)

• Modified Irwin Screen

• Locomotor Activity

• Rotor-Rod

 

Cardiovascular System - Telemetry (Canines, Monkeys, Pigs)

• Activity

• Blood Pressure

• Body Temperature

• Electrocardiogram (QT/QTc)

• Heart Rate

Respiratory System (Rats, Canines, Monkeys)

• Capnography (SpO2, ETCO2)

• Respiratory rate

• Plethysmography

Supplemental Battery Tests

Central Nervous System (Rodents)

• Analgesia Test (Tail Flick)

• Barbiturate - induced sleeping time

• Learning and memory

• Pro-convulsant Activity

• 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

Autonomic Nervous System and Smooth Muscle Evaluation

 

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