Bioequivalence and Bioavailability Forum • BCS?

BCS? [Design Issues]

posted by jag009 – NJ, 2012-11-28 22:22 (4952 d 07:46 ago) – Posting: # 9623
Views: 12,459

Hi Helmut,

I don't see how A-M-R can bypass BE studies other than going with BCS classifiation (FDA?). Having said that, if he goes with BCS it will probably be cheaper and less time consuming in the long run? He also needs to make sure that the reference product is rapidly dissolving (as per FDA guidance).

John

Complete thread:

mebeverine A-M-R 2012-11-22 11:32
- mebeverine drgunasakaran1 2012-11-22 11:47
  - mebeverine bioequivalence A-M-R 2012-11-22 12:12
    - mebeverine bioequivalence jag009 2012-11-28 15:58
      - BCS? Helmut 2012-11-28 16:10
        
        BCS?jag009 2012-11-28 21:22
        
        BCS? Helmut 2012-11-28 21:52
        
        BCS? The Outlaw Torn 2012-11-29 08:58
        
        BCS? jag009 2012-11-29 15:23
        
        BCS? The Outlaw Torn 2012-11-29 15:46
        
        BCS? Tina 2013-10-03 16:24