Bioequivalence and Bioavailability Forum

Hi Matesh M,

❝ Is it possible to demonstrat of Three way Pivotal bioequivalence study, Two reference (from different regulatory) and one test ?

Yes.

❝ I would like to ask can we submit the same three way study to different regulatory like US FDA and TGA?

It is possible, but you may need to include two different ways to analyse the data for FDA and TGA, respectively.
FDA would probably prefer you to make the analysis on basis of all data, that is, for calculation of the model residual which translates into the width of the CI you include the "TGA-reference".
For the TGA submission the agency might wish yo to exclude the "FDA-reference" from the analysis since they tend to lean on EU guidelines.

If you submit an all-treatment analysis anyway to TGA there is a decent chance they won't notice or protest against it.