Biowaiver for Capecitabine - FDA x EMA [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2015-09-09 20:42 (3442 d 04:30 ago) – Posting: # 15392
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Dear Dan, thank you for your explanation.
I agree partially with your position and in addition, as we know, Capecitabine tablets are to be taken orally 30 min after food intake. I think that the increase of pH range after food intake does not allow the change the stability of capecitabine as described in EMA.

P.S. "Stability in acidic media is a substance specific property" ....as well as the solubility ( correct ?)!

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