Bioequivalence and Bioavailability Forum

Reversed procedure? [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-07-04 13:50 (2121 d 13:07 ago) – Posting: # 19018
Views: 31,971

Thank you Lampshade! LMAO at the video...got to watch the movie!

Very comforting that you see it this way too. And I found a precedent where the CHMP ruled on this very issue during an arbitration hearing, though the initial application was 10a and shouldn't have been eligible, or needed, to use the BCS biowaiver option.

I'd love to go to Prague. Love it the first time I went. I'd noticed that Henrike Potthast would be there and worked on ICH M9, with Jan Welink from the EU side. Might be able to convince someone around here that it's worth attending! Thanks again, Helmut.

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 III The 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