Bioequivalence and Bioavailability Forum

Biphasic IVIVC Model [Dissolution / BCS / IVIVC]

posted by Helmut  – Vienna, Austria, 2012-11-19 16:24 (4958 d 21:34 ago) – Posting: # 9553
Views: 6,365

Hi Simon!

❝ John, I would build my model on the single entity/whole capsule;

Hhm. Once the capsule releases the beads (generally within less than 30 minutes) they act as independent doses, IMHO. Most commonly one part is IR and the other part controlled or delayed release.

❝ I think this is fairly common formulation design

True.

❝ and I've certainly seen IVIVCs successfully constructed around these to aid development.

Interesting!

❝ I don't know if anyone has tried to apply for a biowaiver but I will ask our consulting group

Biowaivers are not applicable to controlled / delayed release formulations (only IR).

❝ PS found an example; […] I have this in PDF but not sure how to attach here

Sorry, not possible. @John: Use Simon’s e-mail link to contact him directly.

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Helmut Schütz


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Complete thread:

• Biphasic IVIVC Model jag009 2012-11-07 22:18 
  • Biphasic IVIVC Model Helmut 2012-11-08 00:27
  • Biphasic IVIVC Model SDavis 2012-11-19 08:27
    • Biphasic IVIVC ModelHelmut 2012-11-19 15:24
      • Biphasic IVIVC Model jag009 2012-11-20 17:07
        • That's why! ElMaestro 2012-11-20 17:19