Bioequivalence and Bioavailability Forum

Hi Hiren379,

❝ We are sure that there shall be no/very less variability due to formulation as all the three products are manufactured by us on same platform with same excipients/process/manufacturing location, which is not the case in BE study as Test and reference product are based on different platforms/manufacturing process/location etc. Hence we want to remove this variability part from total variability while calculating sample size

This is not meaningful. By using treatment as a fixed factor (which is always done in BE regardless of design) you account for that. In other words, changes in excipients/process/manuf. location may be expected to affect the GMR but not the variability.