Bioequivalence and Bioavailability Forum

Hi Mikkabel,

❝ My company plan to perform a 4-arm PK study with two arms for two different doses of the test formulations and two arms for two different batches of the reference treatment.

It is not an optimal design; if you want to scale the acceptance range, then it is potentially tricky that you are using different batches of the reference product. It may -in the eyes of a regulator- be seen as a design feature intended to inflate the s_wr and force the CV upwards for scaling.
Your design is one often chosen to companies a bit new in BE, perhaps more well versed with innovator development or formulation technologies, and who wish to squeeze a lot info out of a single trial. It is too optimistic, but you can't readily find info about it in the public domain.

If you are new to BE then be aware that these aspects about scaling are some of the most heavily debated parts of the latest guideline revision. Therefore I don't recommend you to gamble that an expert of sorts can make the trouble disappear if a regulator starts asking questions.

Have a good day.