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RegisterBCS waiver [Dissolution / BCS / IVIVC]
Hi!
Bad news for you!
According Capecitabine Product-Specific Bioequivalence Guidance from EMA, Capecitabine is an unstable compound in acidic medium. Absorption is almost complete. The available data on solubility does not allow its BCS classification. Then, I think that a possibility for biowaiver of capecitabine is impossible according current rules.
Bad news for you!
According Capecitabine Product-Specific Bioequivalence Guidance from EMA, Capecitabine is an unstable compound in acidic medium. Absorption is almost complete. The available data on solubility does not allow its BCS classification. Then, I think that a possibility for biowaiver of capecitabine is impossible according current rules.
Complete thread:
- BCS waiver meghalvakil20 2016-04-27 23:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS waiver nobody 2016-04-28 08:31
- BCS waiverMauricio Sampaio 2016-05-18 15:58
- BCS waiver skycity 2017-01-04 08:19
Ing. Helmut Schütz