Bioequivalence and Bioavailability Forum • IVIV (no C)

IVIV (no C) [Design Issues]

posted by Dr_Dan – Germany, 2011-01-18 12:55 (5639 d 11:38 ago) – Posting: # 6442
Views: 5,610

Hi Helmut,
you are right. All I wanted to say is that regarding bioequivalence you can not (only) rely on your dissolution results. At the moment Rahul has a formulation showing comparable dissolution but no bioequivalence. Maybe his dissolution method does not discriminate sufficiently? It is a poorly soluble drug with low bioavailability. These drugs are a nightmare even if you just copy the reference formulation. Once you have a bioequivalent product it is IMHO easier to find reasons for the discrepancy than the other way round.
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Drug X BE study rahul dixit 2011-01-14 09:00
- Drug X BE study Dr_Dan 2011-01-14 14:57
  - Drug X BE study rahul dixit 2011-01-15 07:53
    - Drug X BE study Dr_Dan 2011-01-17 14:59
      - Drug X BE study rahul dixit 2011-01-18 06:00
        
        Drug X BE study Dr_Dan 2011-01-18 09:40
        
        IVIV (no C) Helmut 2011-01-18 11:11
        
        IVIV (no C)Dr_Dan 2011-01-18 11:55
        
        IVIV (maybe C) Helmut 2011-01-18 15:23
        
        IVIV (maybe C) rahul dixit 2011-01-19 05:14
        
        IVIV (maybe C) Dr_Dan 2011-01-19 10:07
        Posture Helmut 2011-01-19 10:52
        
        Posture rahul dixit 2011-01-19 13:28