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Registerpre-dose concentrations above LLOQ: useful topics [Bioanalytics]
Dear Mitesh,
I think you can find the answer in the following topics: here, here or here
In a nutshell:
EMA BE GL states:
Reanalysis of study samples should be predefined in the study protocol (and/or SOP) before the actual start of the analysis of the samples.
EMA bioanalytical method validation GL states that:
In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason, the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided
Hope it helps
I think you can find the answer in the following topics: here, here or here
In a nutshell:
EMA BE GL states:
Reanalysis of study samples should be predefined in the study protocol (and/or SOP) before the actual start of the analysis of the samples.
EMA bioanalytical method validation GL states that:
In case of reanalysis because of positive pre-dose samples or because of a pharmacokinetic reason, the reanalysed samples should be identified and the initial value, the reason for reanalysis, the values obtained in the reanalyses, the finally accepted value and a justification for the acceptance should be provided
Hope it helps
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Pre-dose concentration found higher than preceding sample Mitesh Panchal 2015-08-30 04:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pre-dose concentrations above LLOQ: useful topicsmittyri 2015-08-30 19:24
- pre-dose concentrations above LLOQ: useful topics Mitesh Panchal 2015-08-30 20:14
- pre-dose concentrations above LLOQ: useful topicsmittyri 2015-08-30 19:24
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