Bioequivalence and Bioavailability Forum

Dear John!

❝ […] truncated AUC 0-72 hrs. Is it applicable only for generic filing or it also applies to supplemental NDA filing? ie, changing from a Tablet to a Capsule (same strength, same indication), from capsule to a tablet,…

I don’t see any reason why the justification (completed absorption of IR products) should not be applicable to NDAs. See the introduction of the FDA’s Guidance:

This guidance is intended to provide recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supple­ments. […] We believe that the guidance will be useful for applicants planning to con­duct BA and BE studies during the IND period for an NDA, BE studies intended for sub­mission in an ANDA, and BE studies conducted in the postapproval period for cer­tain changes in both NDAs and ANDAs.

❝ … dosage strength proportionality studies?

IMHO that’s an exception. Think about nonlinear PK (saturation, autoinduction). In dose-proportionality studies we are not only interested in absorption but also in detecting potential changes in clearance and therefore would assess primarily AUC_0-∞.

❝ Claymore? I always wanted a samurai sword myself

Yep.