Bioequivalence and Bioavailability Forum • Very strange!

Very strange! [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-05 19:52 (4708 d 11:14 ago) – Posting: # 11213
Views: 6,305

Hi Luvbloom,

❝ By the way did you checked Watson's approval. They did studies on 60 and 30 mg istead of 90 and 60 mg and they have not claimed for 90 mg.

Going there now...

Did you look at my post "strange"? What do you think? But was Waton's nifedipine for Adalat CC or Procardia XL? If for adalat CC, since the 60 mg is the RLD listed then I guess they can run studies on 60 and 30mg only to file. But that particular guidance is really strange, asking for fasting (can be HVD design) on 90mg, 2x2x2 on fed on 90mg and 2x2x2 fast on 60mg. I don't get the logic..

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