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

posted by ElMaestro  – Belgium?, 2014-08-21 15:31  – Posting: # 13417
Views: 32,960

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 :waving:

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

 Admin contact
20,801 posts in 4,354 threads, 1,446 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: 01:56 UTC (Europe/Vienna)

Medical statistician: One who will not accept that Columbus discovered America…
because he said he was looking for India in the trial plan.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz