Bioequivalence and Bioavailability Forum • API = salt?

API = salt? [Regulatives / Guidelines]

posted by Melkor – Greece, 2014-01-20 16:28 (4539 d 11:30 ago) – Posting: # 12207
Views: 5,494

Hi Helmut,

Thanks a lot for the prompt response. That was exactly what i was thinking about this issue. Nevertheless, something that is still unclear to this part of the biowaiver: Both formulations: bio-strength and waiver-strength have to have less than 5% of the active substance? :confused:

Thanks again ;-)

Complete thread:

Biowaiver for low-strength (<5%) Melkor 2014-01-20 13:59
- 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 formulations Ohlbe 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