Bioequivalence and Bioavailability Forum

Group effects FDA/EMA [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2014-08-21 19:31 (3525 d 22:44 ago) – Posting: # 13417
Views: 39,354

Hello Mittyri,

❝ 1. Is it obligatory EMA's requirement to use Group effect in the model in all cases when there is more than one group? Any experience of LoDs due to absence of Group effect in the statistical model?

Just include the term.... that can't be bad in a regulatory sense and it can't be a burden to you, right?

❝ 2. What kind of statistical model is preffered for Europe ..

❝ Something like that:

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

Sounds right to me, and I've had thumbs up in sc.advices.

❝ 3. Did you ever got the requests from EMA experts about calculating the CI into one of the groups as for FDA submision?

Not sure what you are actually asking. I have never heard a EU regulator ask for something the FDA want just because of FDA's request in itself.

Hötzi: Enjoy your holidays. I am confident there will be good news in your mehlbox when you return

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 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/EMAElMaestro 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