Bioequivalence and Bioavailability Forum • From Russia (with love?)

From Russia (with love?) [RSABE / ABEL]

posted by PharmCat – Russia, 2019-12-04 15:16 – Posting: # 20924
Views: 226

Hello Helmut!

IMHO, main points:

1. Basic words. Review article.
2. ABEL/RSABE - all have TIE inflation.
3. Biggest inflation when CVintra = 25—30%.
4. EMA aproach better than FDA.

Conclusion:

When you are planning bioequivalence trial better look at EMA guidelines, rather than FDA. We know that all approaches have TIE inflation.

I think this is primarily a message to regulatory experts.

Complete thread:

To Russia (with love?) Helmut 2019-12-04 01:21 [RSABE / ABEL]
- To Russia (with love?) Astea 2019-12-04 07:40
  - From Russia (with love?) Helmut 2019-12-04 10:58
    - From Russia with review mittyri 2019-12-04 11:29
    - From Russia (with love?)PharmCat 2019-12-04 15:16
      - Ignorance is not bliss Helmut 2019-12-04 17:16
        
        Ignorance is not bliss nobody 2019-12-04 18:12
        Ignorance is not bliss - but this is modus vivendi PharmCat 2019-12-04 18:12
        IGNORANCE IS STRENGTH? Astea 2019-12-04 18:15
        
        So sad! Helmut 2019-12-04 19:15
        does existence exist? PharmCat 2019-12-05 11:09