Bioequivalence and Bioavailability Forum • completely new strength

completely new strength [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-10-25 01:05 (4625 d 00:18 ago) – Posting: # 11761
Views: 4,049

Hi Clarc,

❝ 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)

I have a feeling that the devil is in the details. Was 35T, 50R, 70T, 100R tested in the same study? Are you able to prove a dose-response if asked to elaborate on the claim that 35T~50R and so forth. Why would you do a trial with a clinical endpoint if aiming for an EU 10.1 where BE is tightly linked specifically to PK?

—
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 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 strength Clarc 2013-10-24 13:06
        
        completely new strength jag009 2013-10-24 15:47
        completely new strengthElMaestro 2013-10-24 23:05