Discordant outliers [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2019-02-05 18:42 (1877 d 17:14 ago) – Posting: # 19874
Views: 7,181

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
78 visitors (1 registered, 77 guests [including 8 identified bots]).
Forum time: 11:56 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5