Bioequivalence and Bioavailability Forum

Dear Forum Members,

This is regarding the above mentioned subject, my sponsor want to plan a study with four periods and in first two periods the dose will be low and in the next two periods the dose will be double of that given in first two periods. Sponsor also wants to show the dose proportionality along with BE in this study. can any body help in designing the statistical part of this study also. Is it more logical/accurate to conduct a single study on same volunteers or two different studies with two doses? Also if I conduct single study I will have to perform statistical analysis separately for low dose (i.e. period 1 & 2) and that of higher dose (i.e. period 3 & 4), in this situation DF for ANOVA may be different than that of four period study how to take care of that without affecting statistical analysis.

Any help in this regard will be highly appreciated.

Regards,

Ratnakar Jadhav