THX! [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2011-03-19 01:59  – Posting: # 6779
Views: 27,459

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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,346 posts in 4,274 threads, 1,405 registered users;
online 17 (0 registered, 17 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 03:43 UTC

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5