fixed or mixed effects model [BE/BA News]

posted by BEQool  – 2024-09-10 09:35 (92 d 21:18 ago) – Posting: # 24196
Views: 2,364

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

Complete thread:

UA Flag
Activity
 Admin contact
23,336 posts in 4,902 threads, 1,666 registered users;
42 visitors (0 registered, 42 guests [including 13 identified bots]).
Forum time: 05:53 CET (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5