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U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Center for Drug Evaluation and Research, Food and Drug Administration, or Office of Communication, Training, and Manufacturers Assistance, HFM-40,Center for Biologics Evaluation and Research,Food and Drug Administration. May
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U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Guidance for Industry: Nonclinical studies for the safety evaluation of pharmaceutical excipients,Office of Training and Communication, Division of Drug Information, HFD-240, Center for Drug Evaluation and Research, Food and Drug Administration, or Office of Communication, Training, and Manufacturers Assistance, HFM-40,Center for Biologics Evaluation and Research,Food and Drug Administration. May 2005. http://www.fda.gov/cder/ guidance/5544fnl.pdf
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(2005)
Center for Biologics Evaluation and Research, Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients,Office of Training and Communication, Division of Drug Information, HFD-240
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