Bioequivalence and Bioavailability Forum • Group Effect in Full Replicate Design

Group Effect in Full Replicate Design [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2018-09-12 15:09 (1109 d 15:05 ago) – Posting: # 19276
Views: 5,347

Hi Gm,

» We don't want to take any decisions on the basis of model terms.

Very good.

» Our thought is, we need to check group effect for both ABE and RSABE also.

Again: you have to include “group” as a factor in various ways (see below).

» If this correct, how the model is to be designed for RSABE?

As I wrote above

» » Honestly, I have no clue how to modify the models given in the progesterone-guidance.

Specifically the scaling-part…
For the ABE part (if s_wR <0.294) like the FDA’s Model II:

fixed:
Group, Sequence, Treatment, Period (nested within Group), Group-by-Sequence Interaction
random:
Subject (nested within Group × Sequence)

—
Dif-tor heh smusma 🖖
Helmut Schütz

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Complete thread:

Group Effect in Full Replicate Design GM 2018-09-12 07:17 [RSABE / ABEL]
- Group Effect in Full Replicate Design Helmut 2018-09-12 11:20
  - Group Effect in Full Replicate Design GM 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 DesignHelmut 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