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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Greetings team!
I believe that Helmut is correct and without a predefined SOP for repeat analysis, repeat would not be acceptable!
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 
. And for Root cause- most of CRO are not able to identify and thus there would not be a CAPA. 
Thanks,
Dshah
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
I believe that Helmut is correct and without a predefined SOP for repeat analysis, repeat would not be acceptable!
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 . And for Root cause- most of CRO are not able to identify and thus there would not be a CAPA. Thanks,
Dshah
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]
Complete thread:
- Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30
![[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
- 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 Winddshah 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 Wind dshah 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 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
- 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 Winddshah 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