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 07:17 (1133 d 09:37 ago) – Posting: # 19267
Views: 5,883

Dear All,

Hope all are doing well.

We are conducting a BE study of Highly variable drug in patient population. This study will be conducted in 3 groups, which are seperated by one month from each other. There is no clarity in the guidance to check the group effect for this design.

Our doubt is, whether the group effect should be checked in the full replicate design or not?

If so, what are the fixed/random effets need to be checked in RSABE and ABE?

Kindly explain.

—
Best Regards,
GM

Complete thread:

Group Effect in Full Replicate DesignGM 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 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