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RegisterReanalysis reasons [Bioanalytics]
Hello.
First of all as per ICH "reanalysis of study samples for a PK reason (e.g., a sample concentration does not fit with the expected profile) is not acceptable, as it may bias the study result."
However, as a corrective action (CA) you can present BE outcome by including and excluding the subject in question. As a preventive action (PA) you need to update your repeat SOP to avoid such cases.
Regards,
QA
First of all as per ICH "reanalysis of study samples for a PK reason (e.g., a sample concentration does not fit with the expected profile) is not acceptable, as it may bias the study result."
However, as a corrective action (CA) you can present BE outcome by including and excluding the subject in question. As a preventive action (PA) you need to update your repeat SOP to avoid such cases.
Regards,
QA
Complete thread:
- Reanalysis reasons Loky do 2025-11-19 11:40 [Bioanalytics]
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- Reanalysis reasons dshah 2025-11-20 11:04
- Reanalysis reasonsqualityassurance 2025-12-05 14:06
- Reanalysis reasons Achievwin 2026-02-06 12:31
- PK reasons → history Helmut 2026-02-09 11:40
- Blindly (‼) accepting bias? Helmut 2026-02-09 12:41
- Re-analysis: Here we go again ElMaestro 2026-02-09 13:51
- Re-analysis: Here we go-go Helmut 2026-02-10 12:17
- Re-analysis: Here we go again ElMaestro 2026-02-09 13:51
- Reanalysis reasons Achievwin 2026-02-06 12:31
Ing. Helmut Schütz