Bioequivalence and Bioavailability Forum • 5 %: both formulations

5 %: both formulations [Regulatives / Guidelines]

posted by Melkor – Greece, 2014-01-22 13:34 (4534 d 05:27 ago) – Posting: # 12226
Views: 5,303

Thank you both for your help and advice. Concerning the strengths that should follow the rule of 5%, indeed imo bio-strength must comply also with the rule. The main issue is salt of base but i agree that one should better follow the more conservative option.

Thank you again.

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 formulations Ohlbe 2014-01-20 17:32
        
        5 %: both formulationsMelkor 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