Bioequivalence and Bioavailability Forum

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

posted by The Outlaw Torn – Europe, 2018-06-21 14:47 (2133 d 12:22 ago) – Posting: # 18941
Views: 32,343

Thank you, Helmut.

❝ If not, dissolution testing is possible but technically demanding.

If you can elaborate, it would be great. If not, that's okay too. I'm still trying to wrap my head around whether there is the need to do dissolution testing in syrups.

Also, Appendix III seems to imply that only solid dosage forms are eligible for BCS-based biowaivers. Is that your understanding?

Cheers for now.

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: SyrupsThe 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