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THX! [BE/BA News]

posted by Helmut Homepage - Vienna, Austria, 2011-03-19 02:59  - Posting: # 6779
Views: 20,629

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. :crying:


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 CVWR (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!

Cheers,
Helmut Schütz
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