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)
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.