Bioequivalence and Bioavailability Forum

Hello GM,

❝ Our in vitro studies are not dissolution studies. These are in vitro permeation studies. In these studies variability is high when compared to in vivo studies. Sample size is small when compared with in vivo studies. In this case, every value will impact the study results. So how can we deal this data, when outliers are present in the data?

I apologise, I automatically thought it was dissolution and I should not have assumed this.
I don't quite know hwo to deal with it. Find a data expert, do some serious juggling of the figures, approach FDA with a controlled correspondence. No time, no budget, client impatient? Do it anyway

❝ One more thing, generally FDA guidance allows us to prove BE on log transformed data. So, on which data outlier test will be performed(either original scale or log scale)?

I am not too much into these studies, but if FDA allow a parametric evaluation on log data then usually it means you are looking for outliers on the log scale. May I don't mean "usually" but "always", probably, I can't think of any case where this wasn't the case.