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

posted by VStus – Poland, 2016-10-20 13:57  – Posting: # 16745
Views: 28,051

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.


Complete thread:

 Admin contact
20,801 posts in 4,354 threads, 1,446 registered users;
online 15 (0 registered, 15 guests [including 6 identified bots]).
Forum time: 04:50 CEST (Europe/Vienna)

Medical statistician: One who will not accept that Columbus discovered America…
because he said he was looking for India in the trial plan.    Stephen Senn

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