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Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, - PharmaFacts
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Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,

Guidances - FDA Guidances

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078928.pdfUCM071597.pdf