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US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Veterinary Medicine, US Food and Drug Administration, “Guidance for Industry: Bioanalytical Mthod Validation,” 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplian c-eRegulatoryInformation/Guidances/ucm070107.pdf#search ='FDA

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