Seven (7)-Day Non-GLP Toxicity Study, Mouse

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BIOLOGICAL INFORMATION
BACKGROUND INFORMATION
This study design is used to evaluate the potential toxicity of the test article(s) after consecutive administration for a seven (7)-day period.
ORGANISM
Mouse
ASSAY INFORMATION
ASSAY TYPE
In Vivo
TESTING INFORMATION
PROCEDURE SUMMARY
A group of 5 male and 5 female ICR mice, weighing 23 ± 3 grams (g), are employed. The animals are randomly assigned to vehicle control and dose groups by a stratified randomization using body weight. Animals are dosed once daily for 7 days by oral administration (PO), or a specific route assigned by the client. Body weights are taken daily for the purpose of determining dose volume, and cage-side inspections are taken and recorded once daily. The food/ water consumption is evaluated once weekly. At the study termination (on Day 8), all animals are necropsied. Following inhalation overexposure to CO₂, mice are completely exsanguinated (for clin path). A terminal 400 μL blood sample is taken from overnight fasted animals for hematology and blood chemistry. Then, gross external and internal observations are recorded. Organ weight data (heart, lung, brain, kidney, spleen, and liver) are collected. Major organs (heart, lungs, brain, kidneys, spleen, and liver) are formalin-fixed and stored for possible histopathology (optional). Suggested Testing: n=10/group (study design dependent). Toxicity assessed at an initial dose of 30 mg/kg (PO). Dosing volume at 10 mL/kg.
TURNAROUND TIME
STANDARD
45 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-1 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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