Bioequivalence and Bioavailability Forum • completely new strength

completely new strength [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-10-21 19:53 (4628 d 08:28 ago) – Posting: # 11722
Views: 4,219

Hi,

❝ Since there is already a publicated study in this regard, performed on the original product, do You think is it possible to skip the absolute-BA or/and the food effect, or there is a need to perform all three of them?

❝ Would it make sense to think about performing a dose proportionality test between the 70 mg test and the 100 mg reference, or would it make sense to develop a 100 mg test, perform a bioequivalence trial for the 100 mg strength, and after this bioequivalence is demonstrated, the 35 mg and 70 mg strength to be submitted, based on a dose proportionality studty???

That's a bit monumental for developing a "middle" strength(s) generic of a product, don't you think? This might be out of line but what is the benefit of 35 and 70 mg strengths of your client's product?

John

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 strength Clarc 2013-10-21 08:01
    - completely new strength Clarc 2013-10-21 10:45
      - completely new strengthjag009 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