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Looking into the future in pharmaceutical development, what is coming down the pipeline?Non-Biological Complex Drugs

  • At: 2012 FIP Congress in Amsterdam (the Netherlands)
  • Type: Presentation
  • By: SHAH, Vinod (N Potomac, MD, United States of America)
  • Co-author(s): Crommelin, J.A. (TI Pharma, Leiden, Netherlands)
    Muhlebach, S. (TI Pharma, Leiden, Netherlands)
    Fluhmann, B. (TI Pharma, Leiden, Netherlands)
    Ramon (TI Pharma, Leiden, Netherlands)
    Weinstein (TI Pharma, Leiden, Netherlands)
    Gaspar (TI Pharma, Leiden, Netherlands)
    von Vlieger (TI Pharma, Leiden, Netherlands)
  • Abstract:

    In contrast to small molecular drug products, the generic paradigm cannot be applied to non-biological complex drugs (NBCD), because full pharmaceutical characterization of the API is not possible. A fully controlled manufacturing process (synthesis) is essential for the physicochemical and biological characteristics of the product and therefore

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Last update 4 October 2019

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