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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Hi Ohlbe
» Confirming the presence of the analyte in a pre-dose sample could be relevant for other types of studies (and even worse, finding analyte in a placebo-treated subject, or animal in a TK study).
Besides non-BE studies, I also noticed that reanalysis to confirm the presence of the analyte in a pre-dose sample is allowed by some BE assessors. Do you think those group of BE assessors are inconsistent? I ask this because, the same assessors will not accept reanalysis of post-dose samples to correct an irregular PK profile.
» Confirming the presence of the analyte in a pre-dose sample could be relevant for other types of studies (and even worse, finding analyte in a placebo-treated subject, or animal in a TK study).
Besides non-BE studies, I also noticed that reanalysis to confirm the presence of the analyte in a pre-dose sample is allowed by some BE assessors. Do you think those group of BE assessors are inconsistent? I ask this because, the same assessors will not accept reanalysis of post-dose samples to correct an irregular PK profile.
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Complete thread:
- Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics]
![[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 WindObinoscopy 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 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 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