Bioequivalence and Bioavailability Forum • completely new strength

completely new strength [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-10-18 16:59 (4632 d 17:36 ago) – Posting: # 11701
Views: 4,345

Hi,

❝ Is there a way to obtain approval for the test product based only on bioequivalence? If yes, what kind of design should we use?

Why not just file a notification to the agency and get an answer first? Better to ask before throwing money away.

John

Complete thread:

completely new strength Clarc 2013-10-18 11:11
- completely new strengthjag009 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

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