Bioequivalence and Bioavailability Forum

Dear Group members,

Background of my question is as follows:
The development of compound X has been progressed with tablets (1mg/formulation A) to Phase II. Tablets 2mg/Formulation B will be used for Phase III and a BE study is being prepared to demonstrate BE between the 2 formulations.

If bioequivalence is not confirmed (out of the accepted range of 0.8-1.25 for Cmax and AUC)
- how to proceed with for future clinical studies? There will be some cases such as:
acceptable range for AUC but not Cmax
acceptable range for Cmax but not AUC
not acceptable for AUC nor Cmax
- What kind of advice can we expect from Agencies regarding BE results?

Many thanks in advance,
Anne