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

posted by dshah – India, 2020-07-20 07:22 (21 d 05:56 ago) – Posting: # 21755
Views: 1,417

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

Complete thread:

Activity
 Admin contact
20,992 posts in 4,375 threads, 1,460 registered users;
online 18 (1 registered, 17 guests [including 9 identified bots]).
Forum time: Monday 13:18 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5