Bioequivalence and Bioavailability Forum • completely new strength

completely new strength [Regulatives / Guidelines]

posted by Clarc – Romania, 2013-10-18 13:11 (4632 d 07:43 ago) – Posting: # 11693
Views: 4,933

Hi all

My problem is related to a generic, whose reference product is 25, 50 and 100 mg. The sponsor however wants to formulate a 35 and 70 mg generic (saying that this way is more effective...??? - I don't want to argue with them...).
Is there a way to obtain approval for the test product based only on bioequivalence? If yes, what kind of design should we use?

Thanks in advance.

—
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello

Complete thread:

completely new strengthClarc 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 strength ElMaestro 2013-10-24 23:05