Bioequivalence and Bioavailability Forum

completely new strength [Regulatives / Guidelines]

posted by Clarc  – Romania, 2013-10-21 10:01 (4629 d 01:31 ago) – Posting: # 11713
Views: 4,164

Thank You ElMaestro

❝ 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.

The sponsor only say that it is more effective using this strength, but does not want to prove it, so the claim is not to make the drug more effective, but to have a different strength on the market.
However You were right about the 10.3., this is the way they should go with it.

Thanks again.

Clarc

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 strength ElMaestro 2013-10-18 15:29
    • completely new strengthClarc 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