Bioequivalence and Bioavailability Forum • Literature, Caco-2

Literature, Caco-2 [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2011-03-31 15:13 (5568 d 05:09 ago) – Posting: # 6843
Views: 3,692

Hi Helmut
do not rely on Henrike Potthast's (BfArM) words! She tends to forget what she said. Regarding complete absorption she points out in our BE BCS I waiver submission that even if you show 100% Bioavailability this will not support the waiver as long as the drug is not stable over the whole pH range.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

BCS biowaiver (EU) Marcel 2011-03-30 13:57
- Literature, Caco-2 Helmut 2011-03-30 14:43
  - Literature, Caco-2 Marcel 2011-03-30 16:02
  - Literature, Caco-2Dr_Dan 2011-03-31 13:13
    - Literature, Caco-2 Marcel 2011-04-11 12:10
      - Literature, Caco-2 Dr_Dan 2011-04-11 15:07
        
        Literature, Caco-2 Marcel 2011-04-13 10:56
  - Literature, Biowaiver monographs CLR 2011-04-07 04:46