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Isotechnika Inc. completes critical study26 Nov 2007 - Isotechnika Inc. announced the results from the rat carcinogenicity study for its lead immunosuppressive drug, ISA247. ISA247 did not exhibit any carcinogenicity up to the highest doses tested in male and female rats over a two year period.Carcinogenicity studies are required by the United States Food and Drug Administration (FDA) and other Regulatory Authorities and are a critical part of the package submitted for marketing approval. Carcinogenicity studies are performed by administering a range of doses of a drug, including a dose considerably higher than the anticipated clinical dose for a period of two years. This timeframe is equivalent to administering the drug over a lifetime in humans. Additional information
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