Isotechnika Inc. completes critical study
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.
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