Outlier Tests [Outliers]
and thank for your patience
❝ Which outlier tests can apply for in vitro studies? Is there any specifications for this?
❝ Whether we can apply the studentized outlier test for in vitro data...? If not please explain the reason.
I don't think this is an area covered very well by guidelines and I am not entirely sure there is a need either.
If you are really hardcore you can look at distribution theory for the points on the time series and then derive critical values; this is in line with the thinking behind studentized residuals for normally distributed data. I have no idea if this would be accepted, but it would at least be very stringent.
If you are softcore, take one step back and ask your self what the impact of outliers is: They increase variability. And for that you have guidance or at least some regulatory practice and precedent to lean on.
When variability goes up, the classical f2 comparison may not be valid and you'll need to provide proof via bootstrapping of f2 that the profiles are similar. Mahalanobis distance was also in play until recently but it went out of fashion. It was simply too difficult to spell and pronounce for Europeans, I believe .
Pass or fail!