Bioequivalence and Bioavailability Forum • Group Effect in Full Replicate Design

Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM – India, 2018-09-12 14:32 (2847 d 11:24 ago) – Posting: # 19271
Views: 10,477

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,
GM

Complete thread:

Group Effect in Full Replicate Design GM 2018-09-12 07:17
- Group Effect in Full Replicate Design Helmut 2018-09-12 11:20
  - Group Effect in Full Replicate DesignGM 2018-09-12 12:32
    - Group Effect in Full Replicate Design Helmut 2018-09-12 13:08
      - Group Effect in Full Replicate Design GM 2018-09-12 13:23
        
        Group Effect in Full Replicate Design Helmut 2018-09-12 15:09
        
        Group Effect in Full Replicate Design GM 2018-09-12 15:19
        
        Group Effect in Full Replicate Design Helmut 2018-09-12 15:31
        
        Group Effect in Replicate Design zizou 2018-09-12 23:30
        
        Group Effect in Replicate Design Helmut 2018-09-13 11:34