Bioequivalence and Bioavailability Forum • Very strange!

Very strange! [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-05 18:45 (4711 d 23:28 ago) – Posting: # 11210
Views: 6,776

Hi Helmut,

❝ 60 mg not RLD is strange indeed. I guess you misinterpreted the guidance. For the 60 mg fasting study I read:...Since they cannot mean the comment on fed studies, this leaves only the 90 mg fasting study with a reference to the progesterone guidance (=HVD…).

Sorry I misread something. This particular guidance is for Adalat CC which has 60 mg and 90 mg as RLDs. Procardia XL has RLD as 90 mg only.
But I don't get why require 90 mg and 60 mg studies?, particular only 1 study for 60 mg...

Oh well...

John

Complete thread:

BE using non RLD zheng791 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