Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers
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Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.
The U.S. Food and Drug Administration (FDA) is in the process of preparing a draft Guidance for Industry document on the statistical aspects of carcinogenicity studies of pharmaceuticals for public comment. The purpose of the document is to provide statistical guidance for the design of carcinogenicity experiments, methods of statistical analysis of study data, interpretation of study results, ...
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