Bioequivalence and Bioavailability Forum

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

posted by Helmut  – 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 ) 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.

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

There.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• BCS III Classification Obinoscopy 2018-04-20 08:09 [Dissolution / BCS / IVIVC] 
  • 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