Bioequivalence and Bioavailability Forum • Missing periods in replicate designs: kill the data?

Missing periods in replicate designs: kill the data? [RSABE / ABEL]

posted by Astea – Russia, 2019-10-21 03:59 (2030 d 13:18 ago) – Posting: # 20711
Views: 12,491

Dear Helmut and other smart people!

❝ Are you talking to me?

Hey, you! Yes, you!

❝ Tricky – IMHO, case by case (should be laid down in an SOP or the SAP, of course). IIRC, Health Canada had a rule that 1 (one!) concentration is sufficient for C_max and 3 (oh dear!) fo AUC. Gone with the wind. THX, HC.

Suppose we have only one measurable concentration and it is as high as C_max of other periods. Even in this case formally we can calculate AUC for linear trapezoidal rule (depending on the rule for BLOQ data of course). And it can be more than 5 percent of geometric mean of other AUC in this period. Leave it or waste it - any choice will be wrong :no:

Complete thread:

Missing periods in replicate designs Helmut 2019-10-16 13:14
- 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