Bioequivalence and Bioavailability Forum • Potvin C in the EU

Potvin C in the EU [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2013-04-17 04:31 (4312 d 04:09 ago) – Posting: # 10425
Views: 45,192

Hi Hötzi,

❝ new experiences from an ongoing MRP. Two studies (first one in two groups due to logistic reasons), Method C (!), all metrics in both studies passed in stage 1 (>80% power in the interim, no α-adjustment = 90% CIs).

Ahhh... MRP - a relic from the bygone ages when your grandad walked around in the snowy alps with bow and arrows looking for deer.

❝ Studies’ models in stage 1:

Fixed: sequence, period, treatment, group, group × treatment
❝ Random: subject(sequence)
❝
Fixed: sequence, period, treatment
❝ Random: subject(sequence)

Accepted by Germany (RMS); no comments from Austria, Denmark, Sweden, and The Netherlands. Spain: “Statistical analysis should be GLM. Please justify. Please provide the NOL.”

❝ OK, I will repeat the analyses with all fixed effects (sigh; identical CIs…). ;-)

Anything to please the assessor. I have a feeling the assessor means LM but might not know what that really means since every LM in SAS is done via PROC GLM.
But honestly, group x treatment?? I'd rather not go down that road. I hope you do not make precedence.

❝ BTW, does anybody know what “NOL” means?

I am fairly sure it is either "No Objection Lertificate" or "Nixon's Obstructive Leprosy". I don't see what else it could possibly be.

—
Pass or fail!
ElMaestro

Complete thread:

Potvin C in the EU Helmut 2013-04-16 17:40 [Two-Stage / GS Designs]
- Potvin C in the EUElMaestro 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 R VStus 2016-10-20 13:57
        
        Fixed effects model with Group term VStus 2016-10-20 13:54
        
        Group effects FDA/EMA zizou 2016-12-31 02:54
        
        Group effects FDA/EMA Helmut 2017-06-03 14:57
        
        2 Groups model FDA hiren379 2013-08-22 14:32
        
        Homework Helmut 2013-08-23 11:53