Qualitative analysis of the ANOVA residuals [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2014-02-19 16:25 (2408 d 06:52 ago) – Posting: # 12456
Views: 16,665

Hi Lucas,

» […] So I thought that you guys had experience with that being required in other countries.

Limited experience. Once I had to deal with studies on a HVD (pre-scaling age) where the spon­sor – based on previous experiences – stated in the protocols that based on assessing the resid­uals (box­plots and Shapiro-Wilk test) in case of non-normality the study will be evaluated by a non­parametric method. The Dutch agency didn’t like that. In a hearing in The Hague the told me that “We in The Netherlands don’t believe in nonparametric statistics”. ;-)

» Doesn't seem to be a criteria for saying if the results are good or not, am I right?

In Canada you may exclude outliers if you have stated criteria in the protocol.

» » [...] and with a little bit of struggle – in Phoenix/WinNonlin.
» Can u tell me how it can be done at Phoenix?

I’m currently struggling with some PopPK/PD-models which send my CPUs’ load to 80%. I don’t want to start concurrently another PHX-session because it would exceed my RAM and Phoenix would start swapping memory to disk. If I don’t come up with something in the next two weeks, remind me. Some hints in my whitepaper (Section 3.6) about EMA’s ABEL.

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Helmut Schütz
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