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The amount of information on 21 CFR 312. 23 a 7. For general guidance on analytical procedures and methods validation information to be submitted for phase 1 studies sponsors should refer to the FDA guidance for industry on Content and Format of Investigational New Drug Applications INDs for Phase 1 Studies of Drugs Including WellCharacterized Therapeutic Biotechnology-Derived Products November 1995. General guidance regarding analytical procedur...

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