Bioequivalence and Bioavailability Forum • BCS?

BCS? [Design Issues]

posted by The Outlaw Torn – Europe, 2012-11-29 09:58 (4956 d 09:54 ago) – Posting: # 9630
Views: 12,478

❝ With nothing published this will be a tough job (I wouldn’t even think about it). Even if one overcomes all these obstacles, the risk assessment will be the show-stopper.

Goodmorning Europe and Hello ROW,

Helmut, would you mind expanding a tad on what you mean by the risk assessment being a party pooper? Is it because mebeverine doesn't have much of a history (sparce published literature data, as you mentioned) or any post-marketing data? Are you talking pharmacovigilance here?

Although we haven't personally gone the BCS biowaiver route yet, it would be useful to have a more comprehensive understanding of the process.

Thanks.

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