Bioequivalence and Bioavailability Forum • Subjects in replicate BE study EU/FDA

Subjects in replicate BE study EU/FDA [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2015-03-02 12:38 (3336 d 17:48 ago) – Posting: # 14521
Views: 27,065

Dear Relaxation.

❝ As a quick example (method A on the EMA dataset I (?, the 4 period one))

❝ Original result:

❝ 115.66 (107.11-124.97)

❝ Incomplete subjects excluded by hand:

❝ 115.46 (106.49-125.19)

❝ [no 11/20/24/31/42/67/69/71] --> no automatic excludion of incomplete data sets

All the subjects with incomplete data in the EMA dataset I have at least one period with T and one with R. Thus they of course have a contribution to the evaluation of T-R and you will find differences if including or excluding them.

❝ For the show, subject 100 with R twice with values of 1000 and 500 added:

❝ 112.21 (1.16-10833.43)

❝ --> even subjects without data for a T vs R comparison have an impact (choosing such values for ln(data) was a little bit too much but is nicely illustrating, isn't it).

Seems here you are totally correct

—
Regards,

Detlew

Complete thread:

Statistical Analysis section of partial replicate BE study cher0424 2015-01-07 06:39 [RSABE / ABEL]
- Subjects to be considered in partial replicate BE study d_labes 2015-01-07 14:45
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-07 15:35
  - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 06:28
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:03
      - Subjects to be considered in partial replicate BE study cher0424 2015-01-08 09:51
        
        Subjects to be considered in partial replicate BE study d_labes 2015-01-08 10:27
        
        Subjects in replicate BE study EU/FDA Shuanghe 2015-01-08 11:08
        
        Subjects in replicate BE study EU/FDA cher0424 2015-01-08 13:56
        Subjects in replicate BE study EU/FDA Relaxation 2015-03-02 09:46
        
        Subjects in replicate BE study EU/FDAd_labes 2015-03-02 11:38
        Subjects in replicate BE study EU mittyri 2015-03-19 20:12
  - Subjects to be considered in partial replicate BE study Dr_Dan 2015-01-08 08:59
    - Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:04
      - Subjects to be considered in partial replicate BE study Astea 2015-03-01 18:12
        
        Subjects to be considered in partial replicate BE study yjlee168 2015-03-01 19:01
        
        Subjects to be considered in partial replicate BE study Astea 2015-03-09 14:43
        
        NCA with bear? yjlee168 2015-03-09 15:24
        
        Bear and null PK parameters mittyri 2015-03-25 09:50
        
        to exclude or not to exclude the subjects with bear? yjlee168 2015-03-28 21:03
        
        to exclude or not to exclude - let the user decide mittyri 2015-03-29 19:04
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-30 11:28
        
        to exclude or not to exclude - let the user decide ElMaestro 2015-03-30 15:44
        
        to exclude or not to exclude - let the user decide yjlee168 2015-03-31 11:15
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 12:16
        
        Constraints, algebra, jommetry and such yjlee168 2015-03-31 13:13
        
        Constraints, algebra, jommetry and such ElMaestro 2015-03-31 14:26
        
        Constraints, algebra, jommetry and such mittyri 2015-04-01 08:25
        
        Proc GLM, lm() do not auto-exclude subjects d_labes 2015-04-01 09:15
        
        Proc GLM, lm() do not auto-exclude subjects ElMaestro 2015-04-01 16:29