Bioequivalence and Bioavailability Forum

Hi Achievwin,

❝ Are there any limitations on the maximum days allowed between different cohorts (let us say Cohort 1 and Cohort 2) in a Cross over BE study? Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.

I agree with Helmut. There is no real limit in my experience.
From a stats point of view it isn't an issue at all. Of course there are a few situations when you wish to avoid seasonal variations between cohorts (rhinitis or asthma patients etc), but you probably have volunteers?

Re. your sentence "Needless to say the Bioanalysis and PK work will be carried out after completion of all cohorts.": I think it is better in practice to analyse samples after each cohort and accumulate the PK-data until the time of stats analysis.