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Qualification of multisource immediate release proguanil hydrochloride products for BCS based biowaivers

  • At: 2013 FIP Congress in Dublin (Ireland)
  • Type: Poster
  • By: BORN, Gerlinde (Goethe University, Frankfurt, Institute of Pharmaceutical Technology, Frankfurt am Main, Germany)
  • Co-author(s): Nair, Anita (Goethe University, Frankfurt, Frankfurt am Main, Germany)
    Dressman, Jennifer B. (Goethe University, Frankfurt, Frankfurt am Main, Germany)
  • Abstract:


    Background:

    Proguanil hydrochloride is recommended by the WHO for treatment of uncomplicated Plasmodium falciparum infections. The biowaiver procedure based on Biopharmaceutical Classification System (BCS) utilizes dissolution testing as a tool for bioequivalence evaluation instead of in vivo pharmacokinetic studies, thus helping to reduce cost
    ..

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Last update 4 October 2019

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