Bioequivalence and Bioavailability Forum • Very strange!

Very strange! [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-05 18:02 (4711 d 01:18 ago) – Posting: # 11207
Views: 6,331

Hi Luvbloom,

❝ It is ok if you dont want to discuss it further ;-) But there are examples available on Drugs@FDA all you need to do is search. For e.g. Nifedipine.

❝

❝ Period!!

Why do you need to "PERIOD!!"? You were mad or something?

Apparently, you hit a nerve on me with Nifedipine. See Nifedipine ER Draft Guidance. FDA wants 3 studies, a fasting study (can't be a HVD design) on 90 mg the RLD, a fed study on the 90 mg, and 1 fasting on 60 mg. So 90 mg can be HVD and 60 mg is not HVD? I don't get it.. Guidance Dated 9/12

Ok, I assume I can run HVD designs on both 60 and 90...

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