Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 12:32 (1141 d 18:25 ago) – Posting: # 19271
Views: 5,408

Dear Helmut,

Thank you for the quick reply.

» Which agency’s guidance?

FDA Guidance only.

» What do you mean by “checked”? Have group – together with some nested terms – as part of the model (only report the MSEs, p-values) or do you additionally want to base any decision on it? That’s not a good idea, since power might be compromised and the Type I Error inflated (see this presentation).

Sorry for poor english.

» If so, what are the fixed/random effets need to be checked in RSABE and ABE?
  • EMA: all effects fixed
  • FDA: all effects fixed except subject(group × sequence) random

We understand the above and this is as same as 2x2 design. But we thought this is only for ABE approach.

For RSABE approch, only sequence effect will be sufficient in the model? or any group terms need to be include here.

Thank you in Advance.

Best Regards,

Complete thread:

 Admin contact
21,760 posts in 4,550 threads, 1,545 registered users;
online 16 (0 registered, 16 guests [including 5 identified bots]).
Forum time: Thursday 06:57 CEST (Europe/Vienna)

Always remember that you are absolutely unique.
Just like everyone else.    Margaret Mead

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