Bioequivalence and Bioavailability Forum • Drug X BE study

Drug X BE study [Design Issues]

posted by rahul dixit – 2011-01-18 07:00 (5633 d 13:55 ago) – Posting: # 6436
Views: 5,523

Dear Sir,
Thanks a lot.
We could not find the root cause of the variability.

Is matching a dissolution profile in multi pH media with innovator helpful to achieve the bioequivalence ?
With BCS class IV molecules with site specific absorption, what will be the criteria to achive the bioequivalence?
Are there any other tools other than dissolution study to identify the right test formulation to carry out the BE study?
What are the critical things which needs to be added in the study protocol to reduce the variability?
is partial replicate design helpful for class IV molecules?
Regards
Rahul

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 studyrahul 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