Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by dshah – India, 2020-07-20 05:22 (92 d 03:10 ago) – Posting: # 21755
Views: 1,886

Dear Scopy!

Pls note that over here, we are only taking for pre-dose concentration. If the predose concentration>5%, the subject would be excluded from analysis as per most of the guideline. Pls find following example to illustrate that the impact on AUC would not be significant.

» » If we are focusing on root cause, I believe that for pre-dose concentration even in period-I would not cause a significant issue to final BE out come as it may only impact AUC and it would not be significant.:-D If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation:-).
»
» How can you be so sure that its effect on AUC won't be significant? The removal/or inclusion of a subject from a statistical evaluation is enough is change the outcome especially if the result is borderline.

The concentration in below table is shown where only Pre-dose concentration is changed ;-) and then AUC is given using PKSolver.

time concentration 1 concentration 2 concentration 3 concentration 4
0          0               2               4               5
0.25       9.5             9.5             9.5             9.5
0.5       23              23              23              23
0.75      45              45              45              45
1         80              80              80              80
1.5      100             100             100             100
2         95              95              95              95
3         85              85              85              85
4         75              75              75              75
6         65              65              65              65
8         50              50              50              50
10        35              35              35              35
12        20              20              20              20
14        16              16              16              16
16        12              12              12              12
20        10              10              10              10
24         5               5               5               5
AUC      826.125         826.375         826.625         826.75


I believe that such small change in AUC can be considered non-significant. :-)

Regards,
Dshah

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