Qualitative analysis of the ANOVA resid­u­als [General Sta­tis­tics]

posted by ElMaestro  – Belgium?, 2014-02-19 20:40 (2412 d 11:06 ago) – Posting: # 12458
Views: 16,586

Hi Lucas,

» I don't know if I'm thinking too "statistically", but that wouldn't be very subjective? One can look and think that there are outliers and other can think that there aren't and both would not be wrong, since there is no criteria.

You're right, there is some degree of subjectivity in my proposal. I will argue that this is the case for many if not most qualitative assessments, like for instance a CoA for a injectable where you have a spec like "A colorless or slightly yellowish liquid".

» Anyway, your's is a good way to attend to that requirement from the sponsor, but IMHO a qualitative analysis for the residuals would not add any value to the study, from a regulatory perspective. Am I wrong?

You're right, at least per principle. Regulatory decisions are as far as I know not based on residuals or their distributions in any territory. However, regulators may ask for anything they like ("Please submit all chromatograms for QCs and calibrators injected during validation, maintenance records from 2009-2011 for freezer ZX/Y353, and the phone number of the hot brunette from I.P. who attended the last pre-submission meeting" etc), and they may ultimately use that additional information against you as they please.
No idea why a sponsor would ask you to do this, other than if some newly hired numbercruncher wants to impress her/his boss by asking something that sounds complicated. If Helmut's figure above applies to you data then just submit that, tell the sponsor you think this looks reasonably normal (as in Gaussian) without the presence of definitively aberrant values (you will deliberately not use the term outliers).

I could be wrong, but...

Best regards,

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

 Admin contact
21,081 posts in 4,397 threads, 1,468 registered users;
online 9 (1 registered, 8 guests [including 2 identified bots]).
Forum time: Monday 08:47 CEST (Europe/Vienna)

A central lesson of science is that to understand complex issues
(or even simple ones), we must try to free our minds of dogma and
to guarantee the freedom to publish, to contradict, and to experiment.
Arguments from authority are unacceptable.    Carl Sagan

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