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Experience with comparative dissolution studies according to the fda guidance for biowavers
- In: SIG Bioavailability / Bioequivalence - Poster Session
- At: Salvadore (Brazil) (2006)
- Type: Poster
- Poster code: BB-P-014
- 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.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.
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Last update 2 July 2026