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

posted by Helmut Homepage – Vienna, Austria, 2018-06-21 14:21 (1922 d 20:28 ago) – Posting: # 18940
Views: 31,986

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]) 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]. Might be false positives. Duno.

❝ Not sure about the flag thing (I can't see any flags);


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