Bioequivalence and Bioavailability Forum

Dear ioanam!

❝ I just found that our client want in the bioequivalence study to compare the higher strength for the test with the same strength of the reference marketed in Europe versus USA. Is this possible? In the bioequivalence guidelines is specified that the reference must be the innovator. I did not found other 3 way crossover studies to investigate this.

So your comparisons will be:
Test (1000 mg) vs. ‘Reference A’ (1000 mg) EU and
Test (1000 mg) vs. ‘Reference B’ (1000 mg) US

Why not?
Of course ‘Reference A’ must be an innovator’s product registered within the EEA (European Economic Area) or Switzerland (Mutual Recognition Agreement-Country), and ‘Reference B’ the RLD.
In my experience three-way BE studies are more common (and accepted) in the EU than in the USA.