Log in
RegisterDiscordant outliers [Outliers]
posted by Helmut 
– Vienna, Austria, 2019-02-05 18:42 (2256 d 06:15 ago) – Posting: # 19874
Views: 9,067
Hi Mittyri,
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:
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.
❝ 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? 
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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Rules acc. to Health Canada Helmut 2019-02-05 15:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health Canada ElMaestro 2019-02-05 17:33
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
- Rules acc. to Health Canada Helmut 2019-02-05 17:52
- for either the test or reference product? mittyri 2019-02-05 15:58
- Discordant outliersHelmut 2019-02-05 17:42
- Rules acc. to Health Canada Shuanghe 2019-02-06 11:48
- Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
- Rules acc. to Health Canada zizou 2019-02-06 20:52
- Great post! Helmut 2019-02-07 10:37
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
Ing. Helmut Schütz