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Qualitative analysis of the ANOVA resid­u­als [General Sta­tis­tics]

posted by ElMaestro - Denmark, 2014-02-19 20:40  - Posting: # 12458
Views: 9,474

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).

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Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

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