Bioequivalence and Bioavailability Forum

Hi Guys,

❝ ❝ 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.

The problem I am facing is the time scaling part. My data shows two distinct time scaling "regions" and I don't see how I can do the time scaling on the single entity/whole capsule since it's an IR & ER combination formulation.

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

Why not? It's and IR/ER combo. I checked a few SBOAs and there are a few submissions with IVIVCs. However, those IVIVCs failed because the prediction errors exceeded the regulatory limits. Nonetheless the companies filed their IVIVCs and FDA's rejected the IVIVCs based on the prediction errors.

I don't get it. Why did they file if the results were no good

Thanks
John