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RegisterHealth Canada: read the guidance [Outliers]
posted by Helmut 
– Vienna, Austria, 2021-05-27 12:14 (744 d 11:48 ago) – Posting: # 22371
Views: 1,049
Hi Suraj,
adding to Dr S Gunasakaran’s comments:
Next time read the respective guidance before planning the study.
adding to Dr S Gunasakaran’s comments:
- The procedure to deal with outliers has to be stated in the protocol.
- Identification of outliers should be based on a test. ±3 studentized model residuals is recommended. The magnitude of the deviation of the observed values is not relevant.
- The procdure should be followed before the study is assessed for BE.
Next time read the respective guidance before planning the study.
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Helmut Schütz
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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:
- Exclusion of Outlier Data surajpatel 2021-05-27 08:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion of Outlier Data drgunasakaran1 2021-05-27 08:58
- Health Canada: read the guidanceHelmut 2021-05-27 10:14
Ing. Helmut Schütz