Bioequivalence and Bioavailability Forum

If the reference product does not pass in BCS ?? [Dissolution / BCS / IVIVC]

posted by Mauricio Sampaio  – Brazil, 2018-01-10 14:59 (2734 d 06:42 ago) – Posting: # 18160
Views: 4,484

Dear Steven

❝ My guess would be that the reference product does not achieve the pre-set limit of 85% at 15 or 30 minutes, if you say "does not pass"? Could that be right?

YES!!!!

❝ But you will always have to discuss it and provide a convincing statement, so its hard to provide the one solution here.

Thank you for your comments Steven! I think so that a bioequivalence test in vivo is so close to be requested as a second step!

Complete thread:

• If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-08 19:59 
  • If the reference product does not pass in BCS ?? ElMaestro 2018-01-09 05:35
    • If the reference product does not pass in BCS ?? Mauricio Sampaio 2018-01-10 13:52
  • If the reference product does not pass in BCS ?? Relaxation 2018-01-09 16:20
    • If the reference product does not pass in BCS ??Mauricio Sampaio 2018-01-10 13:59