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RegisterBCS-based biowaivers for Class III: Syrups [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2018-06-21 12:21 (1139 d 13:05 ago) – Posting: # 18940
Views: 30,222
Γειά σου κανείς & Outlaw Torn,
» If both (T and R) are solutions (not suspensions) and exhibit no excipients influencing absorption, no need for BE (or BCS biowaiver), in my opinion.
I agree. Sometimes the API tastes terrible (e.g., bitter) and a lot of excipients are added to mask it. Mannitol is not unusual (as a sweetener and to increase viscosity). Then you would be out of the game ⇒ in vivo study.
If not, dissolution testing is possible but technically demanding.
» OT: How to get this cool little EU-flag in the "latest posts" overview on the forum? Do you have an EU-IP or how does this work?
The IP geolocation (under![[image]](https://static.bebac.at/img/CC by-sa.png)
) used in the forum is only ~98% accurate. The commercial product (99.8% accurate) would cost more than my entire domain & webspace. No way.
As of today 0.44% of posts are located in the![[image]](https://static.bebac.at/pics/EU-S.png)
. Might be false positives. Duno.
» Not sure about the flag thing (I can't see any flags);
There.
» If both (T and R) are solutions (not suspensions) and exhibit no excipients influencing absorption, no need for BE (or BCS biowaiver), in my opinion.
I agree. Sometimes the API tastes terrible (e.g., bitter) and a lot of excipients are added to mask it. Mannitol is not unusual (as a sweetener and to increase viscosity). Then you would be out of the game ⇒ in vivo study.
If not, dissolution testing is possible but technically demanding.
» OT: How to get this cool little EU-flag in the "latest posts" overview on the forum? Do you have an EU-IP or how does this work?
The IP geolocation (under
) used in the forum is only ~98% accurate. The commercial product (99.8% accurate) would cost more than my entire domain & webspace. No way.As of today 0.44% of posts are located in the
. Might be false positives. Duno.» Not sure about the flag thing (I can't see any flags);
There.
—
Dif-tor heh smusma 🖖
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 III The 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: SyrupsHelmut 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