Bioequivalence and Bioavailability Forum

❝ In this study, we need to stabilize patients but for how many days neither it is mentioned in specific guidance nor product leaflet. So, what duration we should we consider for stabilization.

Stabilization can be two things PK stabilization (close to steady state) or for treatment stabilization, you have to consult your medical expert or check the summary basis of approval it defines what is stable medication is (this may require certain cycles including drug free period).

Once you determine what is this stabilization period you can always propose a replicate design to achieve efficient patient recruitment and retention.

MY two cents