Bioequivalence and Bioavailability Forum • BCS-based biowaivers for Class III

BCS-based biowaivers for Class III [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-06-21 14:11 (2494 d 08:39 ago) – Posting: # 18939
Views: 33,567

Thanks for the response. Agreed if the situation was as you described. Unfortunately, R (syrup) is discontinued. Tablets are available (API is BCS I), but we are exploring BCS-based biowavers for this product and we're also trying to get familiar with BCS-based biowaiver needs in case we want to go that route with other products too.

Not sure about the flag thing (I can't see any flags); but I requested an "Europe" designation a few years ago to remain incognito in order to be more open on BEBAC. And, yes, I actually am in Europe.

Complete thread:

BCS III Classification Obinoscopy 2018-04-20 08:09
- BCS-based biowaivers for Class III Helmut 2018-04-20 12:15
  - BCS-based biowaivers for Class III Obinoscopy 2018-04-20 16:06
  - BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 09:48
    - BCS-based biowaivers for Class III nobody 2018-06-21 10:33
      - BCS-based biowaivers for Class IIIThe Outlaw Torn 2018-06-21 12:11
      - BCS-based biowaivers for Class III: Syrups Helmut 2018-06-21 12:21
        
        BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
        
        BE of solutions Helmut 2018-06-21 13:33
        
        BE of solutions The Outlaw Torn 2018-06-21 13:39
        BE of solutions The Outlaw Torn 2018-06-27 15:22
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
        
        Reversed procedure? Helmut 2018-07-03 15:33
        
        Reversed procedure? The Outlaw Torn 2018-07-04 11:50
        
        BioBridges Helmut 2018-07-04 12:03