A functional observational battery in non-human primates for regulatory-required neurobehavioral assessments.
BACKGROUND
The objective of this study was to establish a functional observational battery that provided a basic neurological and behavioral assessment fully compliant with requisite governmental regulatory guidelines.


METHODS
Accredited Laboratory Animal Technicians (ALAT) were trained to conduct neurobehavioral assessments in rhesus monkeys prior to and following vehicle (po), 3.2 mg/kg amphetamine (po) and 5.6 mg/kg ketamine (im) administrations. The observational battery was designed to be compliant with the goals of standard veterinary neurological examinations and federal and international regulatory guidelines related to neurotoxicity safety assessments.


RESULTS
A complete neurobehavioral assessment that: 1) was safe for both non-human primate and the animal technicians conducting the assessments, 2) that examined both autonomic and central nervous system functions and, 3) that easily discriminated between the hallmark behavioral pharmacology characterizing respective psychostimulant, dissociative anesthetic, and "normal" (vehicle).


CONCLUSIONS
We believe that these procedures provide safe, effective methodology reflecting contemporary industry's preferred practices for measuring such basic neurobehavioral functioning under the ICH, EPA, and FDA guidelines, and which is amenable to routine use within the context of efficacy, safety pharmacology, and toxicological investigations.
Gauvin
David V
DV
Safety Pharmacology, MPI Research, Inc, Mattawan, MI 49071-9399, United States. david.gauvin@mpiresearch.com
Baird
Theodore J
TJ
D000661:Amphetamine / Q000494:pharmacology*; D000778:Anesthetics, Dissociative / Q000494:pharmacology; D000818:Animals; D001519:Behavior; D001522:Behavior, Animal / Q000187:drug effects*; D000697:Central Nervous System Stimulants / Q000494:pharmacology; D007649:Ketamine / Q000494:pharmacology*; D008253:Macaca mulatta / Q000502:physiology*; D008297:Male; D009422:Nervous System Diseases / Q000139:chemically induced*; D019370:Observation / Q000379:methods*; D015588:Observer Variation
D000778:Anesthetics, Dissociative; D000697:Central Nervous System Stimulants; D007649:Ketamine; D000661:Amphetamine