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Center for Drug Evaluation and Research (U.S.)
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Guidance for industry and review staff : recommended approaches to integration of genetic toxicology study results.
Published 2006
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Guidance for industry : bioanalytical method validation.
Published 2001
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Guidance for industry : extended release oral dosage forms, development, evaluation, and application of in vitro/in vivo correlations.
Published 1997
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Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
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International Conference on Harmonisation
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Center for Veterinary Medicine (U.S.)
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United States. Food and Drug Administration. Office of Regulatory Affairs
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