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Experience with comparative dissolution studies according to the fda guidance for biowavers

  • At: 2006 FIP Congress in Salvadore (Brazil)
  • Type: Poster
  • By: SWANEPOEL, Erna (Research Inst for Industrial Pharmacy, Potchefstroom, South Africa)
  • Co-author(s): Dekker, Theo (Research Inst for Industrial Pharmacy, POTCHEFSTROOM, South Africa)
    Van Tonder, Elsa (Research Inst for Industrial Pharmacy, POTCHEFSTROOM, South Africa)
  • Abstract:

    Aims

    To share experience in performing comparative dissolution studies according to the FDA guidance on the waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms based on a biopharmaceutics classification (BCS) system.

    Methods

    All the studies were performed according to the conditions..

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Last update 4 October 2019

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