Dose Range Finding Study - 12 Rats
Service Description
Provider: Invitek Inc. is a pre-clinical development company in Hayward, California offering a wide range of in-vivo and in-vitro contract research services to the pharmaceutical and biotechnology industries.
Background: A dose range finding is important to determine maximum tolerable dose (MTD). The MTD is defined as a dose that does not produce mortality, more than a 10% decrement in body weight, or overt clinical signs of toxicity.
Service Details: Invitek offers dose range finding/MTD study in SD rats. The study is performed in 6 dose levels and there will be 1 rat/sex/group (total of 12 rats). The test compound will be administered once via one of the routes of administration (PO, IP, IM or SC) or the route intended for human administration. The animals will be observed individually after dosing at least once during 30 minutes, periodically during the 24 hours with special attention given during 4 hours, and daily thereafter for 72 hrs to establish maximum tolerable dose (MTD). Observations include clinical signs, mortality/ morbidity, body weight and food consumption.
Deliverable: Service include draft protocol for review and approval prior to the in-life phase; Draft report and final Report containing all raw data and analyzed results will be delivered to clients.
Sample Submission: Customer may submit either formulated test article or the active pharmaceutical ingredient as a solid (powder). If submitting a solid, customer should provide written formulation instructions. After performing the service all remaining test and control articles will be destroyed unless Client requests sample return.
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