Bioequivalence and Bioavailability Forum

Outlier tests (EMA) [Outliers]

posted by Helmut  – Vienna, Austria, 2010-06-08 17:15 (5063 d 08:44 ago) – Posting: # 5474
Views: 17,925

Dear KR and all,

at last week’s EGA workshop one of the issues was following statement (Section 4.1.10) of the BE-GL

For the acceptance interval to be widened the bioequivalence study must be of a replicate design where it has been demonstrated that the within-subject variability for C_max of the reference compound in the study is >30%. The applicant should justify that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers.

No clarification is given in the presentations, but EMA’s panellists agreed that

• no statistical test should be performed, and
  
• Box plots may be accepted.

Well, box plots are a wide field ( nonparametric by nature!). Keywords: lower/upper adjacent values, inner and outer fence,… Most people would treat values outside the lower/upper quartile ±3× the interquartile range (IQR) as severe outliers (and ±1.5× IQR as mild outliers), but even the method of calculating the quartiles and IQR is not unambigous.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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