Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration

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  • Author(s): Lee, K
  • Source:
    Comprehensive Biotechnology. 2011, v. 3, p439-452.
  • Additional Information
    • Abstract:
      Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration Food and Drug Administration, Bethesda, MD, [...]