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

posted by The Outlaw Torn – Europe, 2018-06-21 09:48 (1266 d 08:52 ago) – Posting: # 18937
Views: 30,559

(edited by The Outlaw Torn on 2018-06-21 10:13)

Hi there Helmut (and anyone else who wishes to help me out),

Long time no talk. I hope all is well.

Regarding the in vitro dissolution requirement for BCS-based biowaivers. Is this needed for aqueous solutions (i.e. syrups)? I can't seem to find any information on aqueous solutions and the BCS.

I did a quick search of the forum for BCS, but couldn't find what I was looking for (some guidance on how to proceed with a BCS-based submission of a syrup). Does anyone know of a good source of information on all that needs to be addressed (proven, etc) in a BCS-based biowaiver justification? By "all" I mean in addition to what Helmut has outlined above and what the guidelines describe, because providing exactly what the guideline asks for is never enough, it seems.

Or is there no BCS option for oral solutions (not a solid dosage form).

I thank y'all in advance.

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