Bioequivalence and Bioavailability Forum

2 Groups model FDA [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2013-04-17 15:10 (4449 d 08:58 ago) – Posting: # 10427
Views: 47,376

Gents!

❝ ❝ But honestly, group x treatment?? I'd rather not go down that road. I hope you do not make precedence.

❝

❝ Not my invention. See this post for the reference.

I have another 'better' one (from a Letter of FDA, Barbara M. Davit)!

" ... the following statistical model should be used when analyzing data from a multiple group bioequivalence study:

Group
Sequence
Treatment
Subject(nested within Group*Sequence)
Period(nested within Group)
Group-by-Sequence Interaction (sic!)
Group-by-Treatment Interaction

Subject(nested within Group*Sequence) is a random effect and all other factors are fixed effects. ..."

Enormous effect(s) .

BTW: Helmut, how had you planned the evaluation of the second stage, if it would be necessary?

BTW2: In context of a 2-Stage design, also a 2-group design with groups here called stage, the mighty oracle prohibit us the Group-by-Treatment Interaction! From the EMA Q&A Rev.7 :
"Conclusion ... A term for a formulation*stage interaction should not be fitted."

BTW3: NOL = no objection letter ?

Complete thread:

• Potvin C in the EU Helmut 2013-04-16 17:40 
  • 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 FDAd_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