Bioequivalence and Bioavailability Forum

THX! [BE/BA News]

posted by Helmut  – Vienna, Austria, 2011-03-19 03:59 (4779 d 10:19 ago) – Posting: # 6779
Views: 34,246

Bless you, sir, and all your house, unto the seventh generation!
You are a most noble and shining example of all that's right and good and true here.

❝ Do you think I have got their points?

Yes. Exactly.

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Edit: Data Set I is funny. Some subjects have missing data in one period, but data in a subsequent one (e.g., subject 11’s third period is missing). Obviously not data from the ‘real world’. Did you have a look at box plots and/or QQ-plots of residuals? What about subjects 45 and 52 (studentized residuals outside ±1.96 and outside 3×IQR)?
Quote from last June’s Q&A:

On a case by case basis, a study could be acceptable if the bioequivalence requirements are met both including the outlier subject (using the scaled average bioequivalence approach and the within-subject CV with this subject) and after exclusion of the outlier (using the within-subject CV without this subject).
An outlier test is not an expectation of the medicines agencies but outliers could be shown by a box plot. This would allow the medicines agencies to compare the data between them.

Excluding subjects 45 and 52 CV_WR (EMA’s method) drops from 47.0% to 32.2%. Maybe that’s a hidden trick question to us:
                     Scaled  AR      width
Full data set:     71.23 - 140.40    69.17
Outliers excluded: 78.79 - 126.93    48.14
The 90% CIs of the full data set of 107.11 - 124.89 (Method A) and 107.17 - 124.97 (Method B) are also within the narrower scaled AR – but it’s a pretty close shave!

—
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:

• EMA BE-GL: Clarifications / Corrections? Helmut 2010-06-22 18:53 
  • Good news!? d_labes 2010-06-23 10:09
    • Good news!? Helmut 2010-06-23 10:11
      • Update Helmut 2011-02-05 18:48
        • Q&A published 14 March 2011 Helmut 2011-03-16 13:44
          • Q&A published 14 March 2011 ElMaestro 2011-03-16 14:20
          • Phoenix/WinNonlin 6.1.0.173 Helmut 2011-03-17 04:23
          • ANOVA party prevails d_labes 2011-03-17 11:00
            • THX!Helmut 2011-03-19 02:59
              • Outlier d_labes 2011-03-24 11:55
                • Outliers - yes, but how? Helmut 2011-03-24 15:09
                  • Questions and Ambiguities d_labes 2011-03-28 14:16
                  • Residuals and Outliers in Replicate Design Crossover Studies d_labes 2011-04-04 08:53
              • Info requested ElMag 2011-03-24 12:45
                • Confused as well... Helmut 2011-03-24 16:50
          • Q&A published 14 March 2011 Priyanka_S 2011-03-21 14:28
            • SAS code: Warning d_labes 2011-03-21 16:08
              • Copy & paste Helmut 2011-03-21 22:38
                • Subtleties, flaws, questions d_labes 2011-03-22 09:24
                  • Subtleties, flaws, questions Helmut 2011-03-27 20:35
                    • Not estimable in the model The user 2017-03-14 10:16
                      • Not estimable in the model ElMaestro 2017-03-14 11:02
                        • Not estimable in the model The user 2017-03-14 12:13
                          • Not estimable in the model ElMaestro 2017-03-14 12:41
                      • Not estimable in the model Helmut 2017-03-18 21:59
                        • Food not the same between groups Beholder 2021-11-10 14:35
                          • Food not the same between groups ElMaestro 2021-11-17 09:50