Bioequivalence and Bioavailability Forum

Qualitative analysis of the ANOVA residuals [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2014-02-19 17:25 (3709 d 04:44 ago) – Posting: # 12456
Views: 20,201

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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 residualsHelmut 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
          • Phoenix → R Helmut 2014-02-23 02:20
            • Phoenix → R Lucas 2014-02-25 19:28
  • 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