Bioequivalence and Bioavailability Forum • Missing periods in replicate designs

Missing periods in replicate designs [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2019-10-16 15:14 (1881 d 02:28 ago) – Posting: # 20690
Views: 14,687

Dear all,

sometimes I see reports with a strange pattern of missing periods, e.g., subjects without the 1^st period, subjects with only the 1^st and the 4^th, etc. Since I have only the statistical part of the report, I have no clue what was going on.
For the FDA’s RSABE only subjects with complete data (all periods) are used. But this is not the case for the EMA’s ABEL (all subjects with at least one T and R treatment for the calculation of the CI, all subjects with two R treatments for the calculation of CV_wR).

I would say:

If a subject does not show up or withdraws consent before the first dose, that’s the end of the story.
If a subject drops out in later periods, end of the story as well. Why did they come back?

Did you see cases like this? And if yes, do you know why?
I saw even cases where a subject in sequence TRTR had data only of periods 1 & 3. Useless.
Another case: 44 subjects had two administrations of T and R. However, 15 had two administrations of T and 39 two administrations of R. Chance – or what?

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Complete thread:

Missing periods in replicate designsHelmut 2019-10-16 13:14 [RSABE / ABEL]
- Missing periods in replicate designs ElMaestro 2019-10-16 15:10
  - Missing samples Helmut 2019-10-17 10:22
    - Missing ambulatory samples M.tareq 2020-04-09 15:24
      - Missing ambulatory samples Helmut 2020-04-09 16:15
        
        Missing ambulatory samples M.tareq 2020-04-09 16:54
- Missing periods in replicate designs d_labes 2019-10-17 17:22
  - Missing periods in replicate designs ElMaestro 2019-10-17 20:17
    - Missing periods in replicate designs d_labes 2019-10-18 11:48
  - Missing periods in replicate designs Helmut 2019-10-19 14:30
    - Missing periods in replicate designs: save the data? Astea 2019-10-20 14:46
      - Missing periods in replicate designs: save the data? Helmut 2019-10-20 15:23
        
        Missing periods in replicate designs: kill the data? Astea 2019-10-21 01:59
        
        Meaningful data? Helmut 2019-10-21 11:37
- Missing periods in replicate designs Mahmoud 2019-11-06 11:41
  - Kenward-Roger? Helmut 2019-11-06 12:49
    - Kenward-Roger? PharmCat 2019-11-06 14:43
      - Kenward-Roger ≥ Satterthwaite Helmut 2019-11-08 20:57
        
        Kenward-Roger ≥ Satterthwaite PharmCat 2019-11-08 22:08
      - Kenward-Roger - links mittyri 2019-11-08 22:59
        
        Kenward-Roger - links PharmCat 2019-11-09 00:51
        degrees of freedom Helmut 2019-11-09 16:22
        
        degrees of freedom PharmCat 2019-11-09 19:11