Bioequivalence and Bioavailability Forum • Outlier tests (EMA)

Outlier tests (EMA) [Outliers]

posted by Dr_Dan – Germany, 2010-06-15 14:36 (5502 d 18:11 ago) – Posting: # 5513
Views: 19,732

Dear Helmut and all
At the EGA workshop you mentioned Lorelei Lutter pointed out the contradiction in the guideline: On the one hand no outlier test is accepted in order to evaluate the results of a BE study and on the other hand it should be demonstrated that the high within-subject variability in a replicate study is not the result of outliers. The whole problem with outliers is not solved by the regulatory authorities and they refuse to discuss this. Why should I detect outliers if no outlier test is accepted and the whole dataset should be evaluated? I suggest not to perform any outlier test.
I am looking forward to further comments regarding this topic.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

SAS Code for Outlier Detection in 2 way Crossover Study ashwinim13 2008-12-16 13:15 [Outliers]
- SAS Code for Outlier Detection in 2 way Crossover Study atish_azad 2008-12-17 06:22
  - SAS Code for Outlier Detection in 2 way Crossover Study ashwinim13 2008-12-17 09:31
- Lund's test obsolete d_labes 2008-12-17 09:33
- SAS Code for Outlier Detection in 2 way Crossover Study statistician 2010-05-25 11:07
  - Grubbs' test Helmut 2010-05-28 12:10
    - Grubbs' test KR 2010-05-31 15:18
      - Quoting and editing Helmut 2010-05-31 17:59
      - Outlier tests (EMA) Helmut 2010-06-08 15:15
        
        EMA Outlier d_labes 2010-06-15 11:48
        Outlier tests (EMA)Dr_Dan 2010-06-15 12:36
        
        Outlier tests (EMA & Canada) Helmut 2010-06-15 12:56
        
        EMA Outliers present d_labes 2010-06-15 15:40
        
        EMA Outliers present Helmut 2010-06-15 15:59
        
        EMA Outliers present d_labes 2010-06-15 16:14
        
        EMA Outliers present Helmut 2010-06-15 16:29