Bioequivalence and Bioavailability Forum

completely new strength [Regulatives / Guidelines]

posted by Clarc  – Romania, 2013-10-24 15:06 (4630 d 15:48 ago) – Posting: # 11747
Views: 4,161

Thanks John for all the advices

❝ 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?

Yes it can be monumental, however if the sponsor can afford it, I'm not questioning his will.
Now seriously: the sponsor performed some clinical trials (not in EU) and they concluded that the 35 mg test has the same clinical efficiency as the 50 mg reference. The same applies to the 70 mg vs. the 100 mg reference. If this is true, than this middle strength generic will be better tolerated by the patient (think on AE's, and of course on the price too), and the better (anticipated) compliance will make it much more cost-effective versus the concurrent generics. (....my guess)

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 strength jag009 2013-10-21 17:53
          • completely new strengthClarc 2013-10-24 13:06
            • completely new strength jag009 2013-10-24 15:47
            • completely new strength ElMaestro 2013-10-24 23:05