Bioequivalence and Bioavailability Forum • Statistical Analysis section of partial replicate BE study

Statistical Analysis section of partial replicate BE study [RSABE / ABEL]

posted by cher0424 – China, 2015-01-07 07:39 (3391 d 01:31 ago) – Posting: # 14234
Views: 30,532
(edited by cher0424 on 2015-01-07 10:32)

Dear all:
I have a query concerning Statistical Analysis section of partial replicate.
There is a paragraph i quote from one of partial replicate design (EU scope) BE study protocol:

The selection of subjects who complete at least two periods with at least one test and one reference treatment of the study will be included in the pharmacokinetic and statistical analysis.
The Selection of subjects who completes at least two periods with at least one test and one reference treatment of the subject will be considered for Bioequivalence
The subjects who complete minimum of two periods with two references in the study will be included in the statistical analysis to estimate within-subject variability of the reference product (SWR).

It is resonable? Or where is these refer from??

Thanking you advance!!!!!

Edit: Category changed. [Helmut]

Complete thread:

Statistical Analysis section of partial replicate BE studycher0424 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/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