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Impact of Gastrointestinal Stability of Acetylsalicylic acid on the Biowaiver Approval of its Immediate Release Products

  • At: 2012 FIP Congress in Amsterdam (the Netherlands)
  • Type: Poster
  • By: NAIR, Anita (Goethe Universität, Institute of Pharmaceutical Technology, Frankfurt, Germany)
  • Co-author(s): Abrahamsson, B. (AstraZeneca R&D, Mölndal, Sweden)
    Zimmer, M. (YES Pharmaceutical Development Services GmbH, Friedrichdorf, Germany)
    Dressman, J. (Goethe Universität, Frankfurt, Germany)
  • Abstract:

    Background information:

    The Biopharmaceutical Classification System based biowaiver procedure makes it possible to use dissolution testing as a surrogate for
    in vivo

    bioequivalence studies, reducing costs and improving access to generic products. The FDA, EMA and WHO biowaiver guidances suggest consideration of the gastrointestinal drug stability


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Last update 4 October 2019

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