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 author (United States. Food and Drug Administration [FDA], 1997-11-25)