Bioequivalence and Bioavailability Forum • completely new strength

completely new strength [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-10-18 17:29 (4634 d 00:08 ago) – Posting: # 11704
Views: 4,371

Hi Clarc,

❝ generic (...) more effective (...) bioequivalence?

These terms are almost mutually exclusive.
If you target USA then it will be a 505(b)(2) and if you are targeting EU then it will be a 10.3. Not generic. If the claim is to make the drug 'more effective' then BE or TE is not the aim of the pivotal trial - you will be looking at superiority.

—
Pass or fail!
ElMaestro

Complete thread:

completely new strength Clarc 2013-10-18 11:11
- completely new strength jag009 2013-10-18 14:59
  - completely new strength Clarc 2013-10-18 15:10
    - completely new strength jag009 2013-10-21 15:49
- completely new strengthElMaestro 2013-10-18 15:29
  - completely new strength Clarc 2013-10-21 08:01
    - completely new strength Clarc 2013-10-21 10:45
      - completely new strength jag009 2013-10-21 17:53
        
        completely new strength Clarc 2013-10-24 13:06
        
        completely new strength jag009 2013-10-24 15:47
        completely new strength ElMaestro 2013-10-24 23:05