BCS 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 [Dissolution / BCS / IVIVC]
- BCS waiver nobody 2016-04-28 08:31
- BCS waiverMauricio Sampaio 2016-05-18 15:58
- BCS waiver skycity 2017-01-04 08:19