Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers: Draft Guidance. Guidance for Industry and Reviewers
Rockville, MD: U.S. Food and Drug Administration [FDA], 2002 December; 26 p. [Online]. Accessed: http://www.fda.gov/cber/gdlns/dose.pdf [2005 May 3]
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