Bioequivalence and Bioavailability Forum

Hi Angus,

❝ What we are seeking is a measure of the variability of the Tmax paramater in the test formulation and the variability of the Tmax parameter in the reference formulation.

OK.

❝ In the absence of a distribution.

<nitpick>

In the absence of a distribution defined by mean/variance.
Of course, t_max (in NCA!) follows a – though discrete – distribution.

</nitpick>

❝ One can do a frequency plot and a percentile analysis and simply compare to see if one is less variable than the other…

Given the limited sample size in BE studies a histogram doesn’t tell too much. I would rather go with box plots categorized for treatments. Sometimes easier to interpret – especially if you have more than two treatments.