Bioequivalence and Bioavailability Forum • regulatory authorities have a different view

regulatory authorities have a different view [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio – Brazil, 2015-09-17 08:44 (3581 d 00:15 ago) – Posting: # 15412
Views: 10,815

Well..., According new Draft Guidance published by FDA is very difficult to prove the high solubility of Capecitabine during 24 hours in pH 1. Even though this condition is unreal during administration of this drug (Capecitabine tablets are to be taken orally 30 min after food intake).

Thank you so much for your responses Mr. Dan

Complete thread:

Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-08 20:38
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
  - Biowaiver for Capecitabine - FDA x EMA Mauricio 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 viewMauricio Sampaio 2015-09-17 06:44