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Impact of Gastrointestinal Stability of Acetylsalicylic acid on the Biowaiver Approval of its Immediate Release Products
- In: SIG Posters
- At: Amsterdam (the Netherlands) (2012)
- Type: Poster
- Poster code: RSC-P-10
- By: NAIR, Anita (Goethe Universität, Institute of Pharmaceutical Technology, Frankfurt, Germany)
- Co-author(s): Abrahamsson, B. (AstraZeneca R&D, Mölndal, Sweden)
Zimmer, M. (YES Pharmaceutical Development Services GmbH, Friedrichdorf, Germany)
Dressman, J. (Goethe Universität, Frankfurt, Germany) - Abstract:
..
Background information:
The Biopharmaceutical Classification System based biowaiver procedure makes it possible to use dissolution testing as a surrogate for
in vivo
bioequivalence studies, reducing costs and improving access to generic products. The FDA, EMA and WHO biowaiver guidances suggest consideration of the gastrointestinal drug stability 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 28 September 2023