BCS waiver [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2016-05-18 17:58 (3195 d 16:27 ago) – Posting: # 16326
Views: 5,381

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.

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