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)
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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 author (1997)