Subject exclusion [Outliers]

posted by Mohamed Yehia  – Egypt, 2018-10-02 22:45 (723 d 07:59 ago) – Posting: # 19402
Views: 4,321

Dear Ohlbe,

» I have a different understanding. Read the guideline again. The word "outlier" is not used anywhere in this section (and only once in the guideline, on a totally different topic). We're not looking for statistical outliers here, but for subjects who did not swallow the tablet. This 5% thing is just an arbitrary threshold that EMA is ready to accept to assume that the subject spat the tablet out.

a subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentration if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subjects). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.

So I think that we have to check for outlying subjects first then remove those subjects if found then check for the geometric mean . That's why I think that if the subject is not an outlying subject we will include it in the calculation

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! Ohlbe]

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