FDA group model in R [Two-Stage / GS Designs]

posted by VStus – Poland, 2016-10-20 13:57  – Posting: # 16745
Views: 26,394

Dear Maestro,

» I actually lost a bit track of this discussion and I am not exactly sure what the comparisons try to achieve?!?

I'm sorry for confusion. I accept that I for sure may understood this topic completely wrong. I just wanted to address Myttiry's issue of non-similar results between R's lm() and WiNonlin in assessment of the FDA group model 1 and 2 for unbalanced dataset.

I don't have access to SAS or WiNonlin, but I have some study reports assessed via SAS using FDA's group model 1 and 2. So, in regards to Point Estimates, 90% CIs, F and P values for:
FDA Group 1 Group*Treat #Treat:Group in my R output
FDA Group 2
- Treat #Drug in my R output
- Per(Group) # group:prd in my R output
- Subj(Group*Seq) # seq:subj in R
lm() provides same results as PROC GLM

If Russian Authorities require an additional assessment using a group model, R output should be ok. So as PHX, if PE and 90%CI are not calculated using FDA Group Model 1.

Regards,
VStus

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