Guidance for Industry: M3(r2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
Rockville, MD: Center for Drug Evaluation and Research, . 25 p. [Online.] Accessed: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073246.pdf [2011 July 1]
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International Conference on Harmonisation; Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Unknown creator (United States. Food and Drug Administration [FDA], 1997-11-25)
Guidance for Industry: Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act: Drug Safety Unknown creator (United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.); and Center for Drug Evaluation and Research (U.S.), 2011)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use Unknown creator (1997)