Qualitative analysis of the ANOVA residuals [General Statistics]
Hi Lucas,
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".
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 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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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 14:27
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 15:22
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 15:58
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 16:25
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 17:20
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-20 19:07
- First hints for Phoenix Helmut 2014-02-20 20:11
- Phoenix: residuals Helmut 2014-02-21 19:25
- Phoenix: residuals BRN 2014-03-04 15:15
- Phoenix: residuals Helmut 2014-03-04 16:52
- Phoenix: residuals Rosy 2018-10-15 07:03
- Software validation Helmut 2018-10-15 11:43
- Software validation Rosy 2018-10-18 00:38
- Avoid raw residuals Helmut 2018-10-18 17:14
- Avoid raw residuals Rosy 2018-10-18 18:05
- Avoid raw residuals Helmut 2018-10-18 17:14
- Software validation Rosy 2018-10-18 00:38
- Software validation Helmut 2018-10-15 11:43
- Phoenix: residuals BRN 2014-03-04 15:15
- Phoenix → R Helmut 2014-02-23 02:20
- Phoenix → R Lucas 2014-02-25 19:28
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 16:25
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 15:58
- Qualitative analysis of the ANOVA residuals ElMaestro 2014-02-19 15:32
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 16:06
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 16:13
- Qualitative analysis of the ANOVA residualsElMaestro 2014-02-19 20:40
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 15:22