Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]
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. If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation
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❝
❝ 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

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:
- Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics]
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 19:15
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-16 21:48
- PK assessors variability Ohlbe 2020-07-16 23:07
- Sometimes PK assessors ≈ scientists Helmut 2020-07-17 16:11
- PK assessors variability Obinoscopy 2020-07-17 23:48
- Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-16 23:19
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
- Reanalysis for PK Reason: Gone with the Winddshah 2020-07-20 07:22
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-20 14:12
- Positive pre-dose Ohlbe 2020-07-20 14:43
- Reanalysis for PK Reason: Gone with the Winddshah 2020-07-20 07:22
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
- Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:00
- Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-20 07:49
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
- Sightly OT (for once) ElMaestro 2020-07-20 12:12
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
- Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-20 07:49
- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
- PK assessors variability Ohlbe 2020-07-16 23:07
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
- Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
- Reanalysis for Pharmacokinetic Reason Achievwin 2020-07-27 23:47
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10