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- W2891848822 abstract "The FDA draft Guidance for Industry, Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (US Department of Health and Human Services 2001) recommends that a positive dose–response alone in tumor incidence of an individual tumor type be tested at 0.005 or 0.025 and that a pairwise comparison alone of an increase in tumor incidence in a treated group over the control group of the tumor type be tested at 0.01 or 0.05 level of significance for a common or a rare tumor, respectively, in a standard NDA or IND submission with two chronic studies in both sexes of rats and mice. The use of these decision rules (levels of significance) in statistical tests of the drug effect on individual tumor types results in an overall false-positive rate of about 10% in such a submission. However, the decision rules for two types of submissions other than those with two chronic studies in rats and mice were either not discussed or barely mentioned in the 2001 draft guidance document. They are submissions including one chronic study in rats and one six-month study in transgenic mice and submissions including only one chronic study in either rats or mice." @default.
- W2891848822 created "2018-09-27" @default.
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- W2891848822 date "2018-01-01" @default.
- W2891848822 modified "2023-10-05" @default.
- W2891848822 title "Expanded Statistical Decision Rules for Interpretations of Results of Rodent Carcinogenicity Studies of Pharmaceuticals" @default.
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- W2891848822 doi "https://doi.org/10.1007/978-981-10-7820-0_8" @default.
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