July 09, 2016

Safety pharmacology core battery: Nervous system

Aim:

Study is to determine neurobehavioral effects of the test item. This IRWIN test is comprised of a standard observation battery of tests addressing various parameters of central nervous, autonomic nervous system and peripheral motor and sensory systems.

Species:

In mice and rats, special FOB for dogs and minipigs.

Design:

• Limit test or 3 dose group design (3 dose groups are compared to one dose of positive control and a negative control)
• In 2 sexes if sex differences are expected
• Optional with exposure control at Cmax

Outcome:

The behavior parameters are monitored and scored according to a rating scale. Statistical analysis is performed comparing to the values of the vehicle group.

 

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