Central Nervous System (CNS) Safety Pharmacology Studies

Safety pharmacology aims ensuring that the use of pharmacological treatments is devoid of unacceptable risk for the health of patients. The central nervous system (CNS) is one of the vital systems which need to be protected against the potential harmful effects of test items. The present chapter includes some guidance for the selection and the realization of preclinical tests used in the context of CNS safety pharmacology. In contrast with a trend for the growing incorporation of safety pharmacology tests within larger toxicology assays, we think that CNS safety pharmacology remains a development step mandatory to ensure the safe use of test items in human patients. We describe the core battery of tests which provides essential and indispensable information on the risk level associated with the use of a test item. If any risk signal is detected by a test belonging to the core battery, we recommend the realization of supplemental safety studies in order to further evaluate the risk level on specific CNS processes. We present supplemental studies in three major safety domains including dependence/abuse, cognitive functions, and electrophysiological CNS activity.