Statistical test for detection of Outliers [Outliers]

posted by ElMag – 2011-03-03 14:10 (4793 d 00:58 ago) – Posting: # 6694
Views: 7,408

Dear Helmut,

I hope that you are fine!
Can you help me out with the following:
The CPMP/QWP/EWP/1401/98 Rev. 1 states regarding the outliers: "The applicant should justify that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers".
Do have any statistical test in mind (in WinNolin or in SPSS or in another program) by which I can detect the outliers (based on the statistical value of intra-subject variability)? Do the Authorities accept such tests?

I would appreciate your prompt reply!

Thank you!!

ElMag

Complete thread:

UA Flag
Activity
 Admin contact
22,984 posts in 4,822 threads, 1,651 registered users;
38 visitors (0 registered, 38 guests [including 8 identified bots]).
Forum time: 16:09 CEST (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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