Bioequivalence and Bioavailability Forum

Hi HS and PK Colleagues,

I have querry.
In dose proportionality BA study in which Formulation A (11.08 mg X 1 tablet) Vs Formulation B (11.08 mg X 2 tablet) is compared. It is suggested that the before statistical analysis the PK of formulation A which was given as one tablet should be double the plasma concentration than run the PK, and than compare with Formulation B for 90% CI and other statistical analysis.

what more statistical analysis will be required apart from conventional Statistical analysis for 2x2 design.

Is their any additional guidance for the same.

Can you please put some light on this issue.
best Regards