Central Nervous System
Central Nervous System (CNS) studies are conducted in a controlled environment (e.g., limiting extraneous noise, excessive entering and exiting the room, etc.) with a limited number of test systems to allow the observer time to make a number of post dose observations during the day. The ICH S7A Safety Pharmacology (Studies for Human Pharmaceuticals) guidance document states that motor activity, behavioral changes, coordination, sensory/motor reflex responses and body temperature should be evaluated. For example, a Functional Observation Battery (FOB), modified Irwin’s or other appropriate industry-standard test can be used.
The principal core battery CNS test allows for the assessment of multiple behavioral, neurological and autonomic parameters in the same test system. The Irwin Test is an observational method that allows for multi-parameter assessment of nervous system function and is typically performed in rodents. Each individual parameter (grouped indicative of autonomic, neuromuscular, sensorimotor and behavioral) is assigned a score by a trained observer (who is blinded as to treatment group) dependent on the severity of the observed indicator.