Bioequivalence and Bioavailability Forum • Missing periods in replicate designs

Missing periods in replicate designs [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2019-10-17 19:22 (1813 d 14:41 ago) – Posting: # 20701
Views: 10,314

Dear Helmut!

❝ 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. ...

❝ Did you see cases like this? And if yes, do you know why?

Yes, I saw such cases in times I was active.
F.i. a subject refuses consent after the 2nd period but came back due to invention of the investigator (by phone) for the 4th period (arguments: "you will not get payed if you refuse, only if you come back" or "Please, please be so kind to continue because otherwise we have not the scientific success we expected" and so on. See ElMaestros post for other examples.)

What to do with such data? DUNO exactly.
You yourself have described what to do for EMA ABEL or FDA RSABE.
Any case left?

—
Regards,

Detlew

Complete thread:

Missing periods in replicate designs Helmut 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 designsd_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