Modified Irwin Screen, Mouse
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DOCUMENTS/REFERENCES
BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
The “Irwin Screen” is a systematic observational approach for the comprehensive assessment and quantification of the behavioral and physiological state of the animal and its response to drugs. Using this screen permits identification and differentiation of the profile of various classes of pharmacologic agents and their potential for adverse centrally mediated behavioral as well as autonomic functional effects.
ORGANISM
Mouse
ASSAY INFORMATION
ASSAY TYPE
In Vivo
TESTING INFORMATION
PROCEDURE SUMMARY
Groups of 10 ICR mice weighing 23 ± 3 grams (g) are employed. Various doses of the test compound are administered orally (PO). The control group receives vehicle alone. At 0, 0.5, 1.0, 2.0 and 24 hours post-dosing, the animals are viewed by a trained observer, blind as to treatment, for signs and effects related to behavioral, neurological and autonomic actions. All together, 38 different individual observations are noted for each animal and each sign or effect is noted either for its presence or absence or assigned a score ranging from 0 to 8. In this scoring scheme, 4 represents no visible change while 0 represents maximal decrease in sign and 8 represents maximal increase. The animals are also observed for vehicle- or compound-induced mortality during the subsequent 7 day observation period. Suggested Testing: n=10/group (study design dependent). Adverse effects assessed at initial doses of 10, 30 and 100 mg/kg. Dosing volume at 10 mL/kg.
CRITERIA FOR SIGNIFICANCE
Score 0 to 8 for each of 38 individual observations; score of 0= maximum decrease, 4 = no change, and 8 = maximum increase.
TURNAROUND TIME
STANDARD
20 Days
CLINICAL RELEVANCE
THERAPEUTIC AREA
CNS/Addiction/Pain
ADDITIONAL INFORMATION
BRAND
PDS
TESTING LOCATION
Taiwan - Taipei
OTHER INFORMATION
We will readily accommodate client-specified alterations. These studies are performed at our AAALAC accredited BSL-2 laboratory in Taipei, Taiwan. All aspects of this work are performed in general accordance with the Guide for the Care and Use of laboratory animals (National Academy Press, Washington, DC, 2011). The study protocol was approved by the Pharmacology Discovery Services IACUC and is performed with the oversight of veterinarians to assure the humane treatment of laboratory animals.
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