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

posted by The Outlaw Torn – Europe, 2018-06-21 12:47 (945 d 00:37 ago) – Posting: # 18941
Views: 29,435

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. :-D 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.

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