Bioequivalence and Bioavailability Forum • Missing ambulatory samples

Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq – 2020-04-09 18:54 (1702 d 18:02 ago) – Posting: # 21328
Views: 10,135

❝ Well, that’s extreme. Did I really give such an example somewhere?

Think it was mentioned here: https://bebac.at/lectures/Leuven2013WS1.pdf#page=37

not specifically AUC_0-12 vs AUC_0-72, but AUC with with different time points

❝ Up to you. As long as you describe the procedure unambiguously in the SAP (which has to be accepted by the agency), fine. That’s my standard procedure for ages. No guideline is that specific.

Guess CRO should have accounted for COVID-19 impact on missingness of ambulatory samples :-D

But as always thanks alot for your prompt reply!

Stay safe and well!

Mahmoud

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 samplesM.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