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RegisterBCS-based biowaivers for Class III [Dissolution / BCS / IVIVC]
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.
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.
Complete thread:
- BCS III Classification Obinoscopy 2018-04-20 08:09 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 IIIThe 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: Syrups The 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
- Reversed procedure? The Outlaw Torn 2018-07-04 11:50
- Reversed procedure? Helmut 2018-07-03 15:33
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
- BE of solutions Helmut 2018-06-21 13:33
- BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
- BCS-based biowaivers for Class III nobody 2018-06-21 10:33
- BCS-based biowaivers for Class III Helmut 2018-04-20 12:15
Ing. Helmut Schütz