Bioequivalence and Bioavailability Forum • BE using non RLD

BE using non RLD [Regulatives / Guidelines]

posted by zheng791 – US, 2013-08-03 23:45 (4707 d 11:34 ago) – Posting: # 11187
Views: 7,077

Hi All,
I am compiling the ANDA dossier and found the BE was conducted by using generic 75 mg vs Brand 75 mg. The RLD is 300 mg. When I checked the guidance, they always said RLD. Is this BE acceptable?

Thank you very much

Complete thread:

BE using non RLDzheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLD jag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLD jag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLD ElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange! Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52