RANGE FINDING/ACUTE ORAL TOXICITY OF CHEMOPREVENTIVES

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The National Cancer Institute, Division of Cancer Prevention, Chemopreventive Agent Development Research Group directs an investigational chemopreventive agent development program to identify and develop drugs that will prevent, delay, or reverse the process of carcinogenesis. In order to assess safety of investigational new agents, they must be evaluated for their toxicological potential. A variety of animal studies are used to assess the potential risk posed by candidate new drugs in treating humans. Initially, toxicity studies are conducted in one rodent species (typically rat) starting with oral rangefinding studies and short term oral toxicity studies. The data will be included in an Investigational New Drug (IND) application to FDA which is required prior to initiation of human clinical trials. The battery of tests will include monitoring of gross motor and behavioral activity, food consumption, body weight, observable changes in appearance, clinical signs related to pharmacology and toxicology of the test compound, hematology, clinical chemistry, ophthalmoscopic examination, and macroscopic and microscopic tissue examination. Compound selection for the study will be made from the Rapid Access to Preventive Intervention Development (RAPID) Program. The studies shall fulfill current industry standards for toxicology studies supporting NDA application and shall be conducted under FDA Good Laboratory Practice (GLP) regulations in AAALAC accredited, NIH/OPRR & USDA registered laboratories with active Institutional Animal Care and Use Committee (IACUC).