Discordant outliers [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2019-02-05 17:42 (803 d 13:20 ago) – Posting: # 19874
Views: 4,849

Hi Mittyri,

» maybe I'm only one who is confused with that statement, but:
» 3. The subject in question should be identified as an outlier for all parameters, for either the test or reference product, upon which the bioequivalence decision is to be based.
» Either? Sorry for my poor grammar knowledge but 'either' is a kind of choice, right?

In the combination either – or, absolutely. If you drop the or it is a synonym for each (element of a set).
Either A or B:      A ∨ B
Either of A, B, C: A ∧ B ∧ C

I guess HC means that it doesn’t matter whether an aberrant response is seen after test or reference. Agrees with ICH E9 Section 5.3:

Any outlier procedure set out in the protocol or the statistical analysis plan should be such as not to favour any treatment group a priori.

» So does it mean we need to find out the outliers using the datasets splitted by formulation, not for the ratio T/R? :confused:

Good point. If we split the dataset, we can’t run the model, right? Studentized residuals? Nada.
I guess HC talks about discordant outliers. In other words, it doesn’t matter whether the aberrant response is observed for the test or reference. Like it.

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Helmut Schütz

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