Bioequivalence and Bioavailability Forum • Missing samples

Missing samples [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2019-10-17 12:22 (2020 d 09:49 ago) – Posting: # 20700
Views: 12,628

Hi ElMaestro,

❝ This, I think, relates originally to FDA's data driven policies. A subject can walkout on her/his own initiative without even stating a reason, that's how GCP works. There is no clause saying she/he can't come back.

❝ I know, this is messy, but that's the way it is in some clinics.

I see. Since the data are useless for the FDA’s reference-scaling maybe this was a trick-shot of the CRO to milk the sponsor.

❝ The alternative may be worse, depending on how you look at it: If a subject misses an ambulatory pk-sample […] should she/he then be considered completely out?

I like your examples! That’s an area of improvement which requires a good amount of intellectual horsepower. Not easy but the idea is to come up with rules specifying how many missings (and where) in the profile will likely lead to unreliable estimates of a given PK metric.

—
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Helmut Schütz

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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 samplesHelmut 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