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RegisterQualitative analysis of the ANOVA residuals [General Statistics]
Hi Helmut! Thanks for the fast response, as always.
No, the sponsor wants us to perform that. The study would be submitted at ANVISA, but I think they want a study that can be (if they ever need) submitted at other agencys. I just love how they ask us that kind of analysis without even explaining their objective with that. So I thought that you guys had experience with that being required in other countries. The sponsor is from England, if that helps.
Doesn't seem to be a criteria for saying if the results are good or not, am I right?
Can u tell me how it can be done at Phoenix?
Thanks.
❝ ANVISA?
No, the sponsor wants us to perform that. The study would be submitted at ANVISA, but I think they want a study that can be (if they ever need) submitted at other agencys. I just love how they ask us that kind of analysis without even explaining their objective with that. So I thought that you guys had experience with that being required in other countries. The sponsor is from England, if that helps.
❝ IMHO, assessing the studentized residuals makes sense. See also Canada’s Guidance, Section 2.3.4.
Doesn't seem to be a criteria for saying if the results are good or not, am I right?
❝ [...] and with a little bit of struggle – in Phoenix/WinNonlin.
Can u tell me how it can be done at Phoenix?
Thanks.
Complete thread:
- Qualitative analysis of the ANOVA residuals Lucas 2014-02-19 14:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 15:22
- Qualitative analysis of the ANOVA residualsLucas 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 residualsLucas 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 residuals ElMaestro 2014-02-19 20:40
- Qualitative analysis of the ANOVA residuals Helmut 2014-02-19 15:22
Ing. Helmut Schütz