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Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application - PharmaFacts
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Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application

Guidances - FDA Guidances

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079234.pdf