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RegisterHandling "Not Reportable" Data [Bioanalytics]
Hi Emrah,
Careful, please. If you are submitting in a territory where outlier detection is the norm then perhaps you can neglect the original value after some number crunching gymnastics. But if you are not submitting in a territory where outliers testing is popular then you would perhaps need to either report the value however wrong it sounds, or, audit and self-inspect the study to see if you can verify that something really went wrong (and you need more than just an unexpected value for that); a verification of a problem would then allow you to report the re-analysed value.
❝ I think neglecting that value in PK analysis will be the best practice as ElMaestro advised.
Careful, please. If you are submitting in a territory where outlier detection is the norm then perhaps you can neglect the original value after some number crunching gymnastics. But if you are not submitting in a territory where outliers testing is popular then you would perhaps need to either report the value however wrong it sounds, or, audit and self-inspect the study to see if you can verify that something really went wrong (and you need more than just an unexpected value for that); a verification of a problem would then allow you to report the re-analysed value.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
- Handling "Not Reportable" Data nobody 2014-11-21 08:07
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 08:18
- Handling "Not Reportable" DataElMaestro 2014-11-21 09:53
- Handling "Not Reportable" Data nobody 2014-11-21 11:11
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
- IS carry-over? Helmut 2014-11-21 16:45
- IS carry-over? nobody 2014-11-21 17:19
- IS carry-over? Emrah Soner Özdeş 2014-11-24 08:58
- IS carry-over? Emrah Soner Özdeş 2014-11-27 10:28
- Another story! Helmut 2014-11-27 14:21
- Another story! Emrah Soner Özdeş 2014-11-28 10:00
- Another story! nobody 2014-11-28 10:18
- Another story! Helmut 2014-11-27 14:21
- IS carry-over? Helmut 2014-11-21 16:45
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 16:14
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 08:18
- Handling "Not Reportable" Data AngusMcLean 2014-11-28 19:09
- EMA and similar regulations… Helmut 2014-11-28 19:16
- EMA and similar regulations… jag009 2014-12-01 19:54
- EMA and similar regulations… Helmut 2014-11-28 19:16
- Handling "Not Reportable" Data nobody 2014-11-21 08:07
- Handling "Not Reportable" Data Emrah Soner Özdeş 2014-11-21 07:54
- Handling "Not Reportable" Data ElMaestro 2014-11-21 07:34
Ing. Helmut Schütz