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E 16 genomic biomarkers related to drug response : context, structure, and format of qualification submissions.

Center for Drug Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2009

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Dose-response information to support drug registration.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1994

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