Bioequivalence and Bioavailability Forum • Biowaiver for Capecitabine

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

posted by Mauricio Sampaio – Brazil, 2015-09-09 20:42 (3589 d 08:53 ago) – Posting: # 15392
Views: 11,707

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 ?)!

Complete thread:

Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-08 20:38 [Dissolution / BCS / IVIVC]
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
  - Biowaiver for Capecitabine - FDA x EMAMauricio Sampaio 2015-09-09 18:42
- …as well as the solubility Dr_Dan 2015-09-10 08:52
  - …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
    - regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
      - regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44