CENTRAL NERVOUS SYSTEM STUDIES

CNS Safety Pharmacology is designed to identify behavioral and neurological effects of a test substance.

The basic test used is the Irwin test, often coupled with the activity meter and rotarod tests for a more sensitive and comprehensive evaluation of the effects on activity levels and on coordination. Interaction with barbital-induced loss of righting reflex can also be included.

Although not part of the core battery as defined in ICH S7A, additional tests for the evaluation of the risk of seizures (e.g. PTZ or ECS threshold tests) can also be performed.

A wide range of follow-up studies to better evaluate pro-convulsive potential (e.g. EEG studies) or effects on cognitive performance (e.g. Morris water maze, passive avoidance, social recognition, delayed alternation, operant reversal) are also available to help discharge any perceived risks relevant to potential CNS safety concerns with a test substance.

Examples of follow-up studies

> Convulsive threshold

> EEG trace monitoring 

> Quantified EEG

> Sleep wake cycle

> Mood and stress studies

> Cognition studies