Bioequivalence and Bioavailability Forum

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

posted by Helmut  – Vienna, Austria, 2013-04-16 19:40 (4020 d 23:40 ago) – Posting: # 10424
Views: 45,666

Dear all,

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).

Studies’ models in stage 1:

1. Fixed:  sequence, period, treatment, group, group × treatment
Random: subject(sequence)
   
2. 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…).
BTW, does anybody know what “NOL” means?

P.S.: All metrics would have passed with α_adj 0.0294 (Method B) as well. I did not report these results and interestingly surprisingly was not asked for them.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• Potvin C in the EUHelmut 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/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