Qualitative analysis of the ANOVA residuals [General Sta­tis­tics]

posted by Lucas – Brazil, 2014-02-19 15:58  – Posting: # 12453
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Hi Helmut! Thanks for the fast response, as always.

» 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.

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