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Back to the forum  Query: 2018-04-25 10:43 CEST (UTC+2h)
 

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

posted by Mauricio Sampaio - Brazil, 2018-01-10 13:59  - Posting: # 18160
Views: 568

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!!!!:-D

» 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!:crying:

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