Hi everyone,
I am analyzing a BE study using parallel study design. In the study, the 80 subjects were divided in three cohorts as the clinical site was not able to dose all of the 80 subjects on the same day. To take this variable into consideration, I thought of adding a Cohort to the plasma data file. How should this be captured in the BE tab? Should it be under Fixed Variance as:
Treatment
or Treatment+Cohort
or should I consider the cohort effect as a random factor?
Can you please provide guidance?
Thank you and kind regards,
Alex