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RegisterReanalysis for PK Reason: Gone with the Wind [Bioanalytics]
Dear Helmut,
» » » According to the current guidelines (EMA 2011, FDA 2018, ICH draft 2019) it is no more acceptable. IMHO, bad science.
» »
» » Agreed.
»
» Agreed on what? That is not acceptable or that it is bad science?
That it is bad science, of course ! To accept as a matter of principle data which are obviously incorrect, and to refuse as a matter of principle for these data to be corrected, is something I fail to understand.
I understand that assessors may be suspicious if there were some re-analyses for PK reasons. If the study is only borderline passing, they always have the possibility to perform (or ask for) a statistical analysis with the original data. Depending on the outcome, they may ask for an inspection.
» » » According to the current guidelines (EMA 2011, FDA 2018, ICH draft 2019) it is no more acceptable. IMHO, bad science.
» »
» » Agreed.
»
» Agreed on what? That is not acceptable or that it is bad science?
That it is bad science, of course ! To accept as a matter of principle data which are obviously incorrect, and to refuse as a matter of principle for these data to be corrected, is something I fail to understand.
I understand that assessors may be suspicious if there were some re-analyses for PK reasons. If the study is only borderline passing, they always have the possibility to perform (or ask for) a statistical analysis with the original data. Depending on the outcome, they may ask for an inspection.
—
Regards
Ohlbe
Regards
Ohlbe
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 WindOhlbe 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 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