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Dear Dshah,
The change in AUC is indeed extremely limited, and unless the study outcome is just at the boundary it will indeed not have any influence in itself. But excluding or including a subject, depending on whether his pre-dose concentration is > or < 5% of Cmax, can have dramatic consequences.
❝ 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.
❝ I believe that such small change in AUC can be considered non-significant. 
The change in AUC is indeed extremely limited, and unless the study outcome is just at the boundary it will indeed not have any influence in itself. But excluding or including a subject, depending on whether his pre-dose concentration is > or < 5% of Cmax, can have dramatic consequences.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
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![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
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- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
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- Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
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- Positive pre-doseOhlbe 2020-07-20 14:43
- Reanalysis for PK Reason: Gone with the Wind dshah 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
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- 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
Ing. Helmut Schütz