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

• In: Posters
• At: Dublin (Ireland) (2013)
• 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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