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

• In: 8D2 - Looking into the future in pharmaceutical development, what is coming down the pipeline? on Saturday, 6 October 2012, 14:00-17:00
• At: Amsterdam (the Netherlands) (2012)
• 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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