Bioequivalence and Bioavailability Forum • 5 %: both formulations

5 %: both formulations [Regulatives / Guidelines]

posted by Ohlbe – France, 2014-01-20 18:32 (4545 d 06:40 ago) – Posting: # 12210
Views: 5,378

Dear Helmut,

❝ I would follow the argument in Jean-Michel’s extreme example. Therefore, IMHO the 5% should be based on the API seen from a galenic perspective (e.g., the salt), not the PK perspective (“active moiety”).

I'm not a specialist - but I would agree. This is the most conservative approach, the most protective from the patients' point of view.

—
Regards
Ohlbe

Complete thread:

Biowaiver for low-strength (<5%) Melkor 2014-01-20 13:59 [Regulatives / Guidelines]
- API = salt? Helmut 2014-01-20 14:24
  - API = salt? Melkor 2014-01-20 15:28
    - 5 %: both formulations Ohlbe 2014-01-20 16:21
      - 5 %: both formulations Helmut 2014-01-20 17:04
        
        5 %: both formulationsOhlbe 2014-01-20 17:32
        
        5 %: both formulations Melkor 2014-01-22 12:34
        Active moiety Helmut 2014-01-23 00:54
        
        Change of API and fate of biostudy kumarnaidu 2014-06-27 10:54