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

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

posted by Relaxation – Germany, 2015-03-02 10:46 (3335 d 23:59 ago) – Posting: # 14520
Views: 27,225

Dear all.

Sorry for bringing this thread back to life instead of creating a new one, but as I only think I want to point on one thing, this seemed more appropriate to me.
It was here stated twice that

❝ To state it briefly:

❝ – samples from subjects who complete at least 2 periods will be analysed

❝ – subjects who has 2 periods of R will be included to determine Swr

❝ – subject who can provided at least one T and one R will be included for BE evaluation

❝ The last 2 is "done automatically" as Detlew said but I would prefer to state it very clearly in the protocol just in case. ;-)

and I am not sure, whether I miss something here. From my experience, including the sample data set of the EMA-PKWP, there is no automatism for these subjects, even in case the "method A" / GLM object is used.
In other words, subjects with missing data will be included in the evaluation unless we exclude them by selection.

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
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).

So also subjects with missing periods including those with Reference Data only will remain in the evaluation if we simply use the code and, if wanted, subjects have to be excluded manually beforehand (which for BE assessment seems to be acceptable with EMA only for those with Reference only).

Sorry, if I missed somethin and this is a triviality :-D

. Then feel free to simply ignore the post :-(

. Just wanted to add these piece of info to the "automatic"-statements.

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/FDARelaxation 2015-03-02 09:46
        
        Subjects in replicate BE study EU/FDA d_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