fixed or mixed effects model [BE/BA News]

posted by BEQool  – 2024-09-10 09:35 (205 d 02:01 ago) – Posting: # 24196
Views: 3,930

Hello Helmut,

thank you for the answers.
I just wanted to point out that, if I understand correctly, in ICH M13A basically nothing changes (PE and 90%CI) compared to EMA guideline on how to perform an analysis when periods are missing (because subject is a fixed factor) but compared to FDA guideline (subject as a random factor) PE and 90% CI change a little because now subjects with missing periods have to be excluded from the analysis (and according to FDA guideline you shouldnt exclude them)?

❝ P.S.: I modified the script in such a way that you can specify the number of dropouts and subjects with missings. Try this:

❝    CV         <- 0.15

❝    theta0     <- 0.975

❝    target     <- 0.90

❝    alpha      <- 0.05

❝    per.effect <- 0

❝    carryover  <- c(0, 0)

❝    dropouts   <- 2

❝    missings   <- 1

❝ Interesting, isn’t it?


Thanks, interesting indeed :ok:

Regards
BEQool

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