Bioequivalence and Bioavailability Forum • Missing ambulatory samples

Missing ambulatory samples [RSABE / ABEL]

posted by M.tareq – 2020-04-09 17:24 (1642 d 21:48 ago) – Posting: # 21325
Views: 8,626

❝ 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.

In one of your lectures, you mentioned comparing the two profile as is, meaning AUC_0-12 to AUC_0-72, but won't be comparing orange vs apples, mean, if, for example the first AUC_0-12 (drug A) covers 50% of the profile while the comparator AUC_0-72 (drug B) covers 80%, is this a biased comparison?

Other method that was mentioned in the forum/lectures more often; is is doing log-linear regression using the terminal part of the profile with missing points and perform extrapolation to estimate such points, but no mentioned of such methods in any of the guidelines

my question is: if comparing AUC_0-t as is (missing points are ignored) without doing the extrapolation and the BE criteria not met but when doing the extrapolation the BE is achieved, how such predicament will be handled by the assessor and/or CRO ?

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 samplesM.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