FDA group model in R [Two-Stage / GS Designs]
Dear Maestro,
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 WinNonlin in assessment of the FDA group model 1 and 2 for unbalanced dataset.
I don't have access to SAS or WinNonlin, 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
❝ 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 WinNonlin in assessment of the FDA group model 1 and 2 for unbalanced dataset.
I don't have access to SAS or WinNonlin, 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
Complete thread:
- Potvin C in the EU Helmut 2013-04-16 17:40 [Two-Stage / GS Designs]
- Potvin C in the EU ElMaestro 2013-04-17 02:31
- Potvin C in the EU Helmut 2013-04-17 12:23
- 2 Groups model FDA d_labes 2013-04-17 13:10
- 2 Groups model FDA Helmut 2013-04-17 16:37
- Group effects obsolete? d_labes 2013-04-18 09:55
- Group effects FDA/EMA Helmut 2013-04-19 14:34
- Group effects FDA/EMA mittyri 2014-08-21 15:34
- Group effects FDA/EMA ElMaestro 2014-08-21 17:31
- Group effects EMA mittyri 2014-10-01 11:25
- Group effects EMA ElMaestro 2014-10-01 11:31
- Group effects EMA Helmut 2014-10-01 13:24
- Group effects EMA VStus 2016-10-06 22:06
- Group effects EMA ElMaestro 2016-10-07 12:45
- Group effects EMA mittyri 2016-10-07 15:06
- Fixed effects model with Group term mittyri 2016-10-09 13:27
- Fixed effects model: changing the F, p values mittyri 2016-10-10 18:33
- Fixed effects model: changing the F, p values ElMaestro 2016-10-10 20:10
- Fixed effects model: changing the F, p values Helmut 2016-10-11 00:17
- Holy War of type III d_labes 2016-10-11 13:17
- Significance of Group effect in Russia: why the type III is so 'important' mittyri 2016-10-11 15:07
- Fixed effects model: changing the F, p values zizou 2016-10-11 01:06
- FDA group model in R mittyri 2016-10-11 13:43
- FDA group model in R ElMaestro 2016-10-12 01:07
- FDA group model in R VStus 2016-10-17 15:32
- FDA group model in R ElMaestro 2016-10-17 18:58
- FDA group model in RVStus 2016-10-20 13:57
- FDA group model in R ElMaestro 2016-10-17 18:58
- FDA group model in R mittyri 2016-10-11 13:43
- Fixed effects model: changing the F, p values ElMaestro 2016-10-10 20:10
- Fixed effects model with Group term VStus 2016-10-20 13:54
- Fixed effects model: changing the F, p values mittyri 2016-10-10 18:33
- Fixed effects model with Group term mittyri 2016-10-09 13:27
- Group effects EMA mittyri 2016-10-07 15:06
- Group effects EMA ElMaestro 2016-10-07 12:45
- Group effects EMA VStus 2016-10-06 22:06
- Group effects FDA/EMA zizou 2016-12-31 02:54
- Group effects FDA/EMA Helmut 2017-06-03 14:57
- Group effects EMA mittyri 2014-10-01 11:25
- Group effects FDA/EMA ElMaestro 2014-08-21 17:31
- Group effects FDA/EMA mittyri 2014-08-21 15:34
- Group effects FDA/EMA Helmut 2013-04-19 14:34
- 2 Groups model FDA hiren379 2013-08-22 14:32
- Homework Helmut 2013-08-23 11:53
- Group effects obsolete? d_labes 2013-04-18 09:55
- 2 Groups model FDA Helmut 2013-04-17 16:37
- 2 Groups model FDA d_labes 2013-04-17 13:10
- Potvin C in the EU Helmut 2013-04-17 12:23
- Potvin C in the EU ElMaestro 2013-04-17 02:31