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Hi samar sameh,
Matrix effect and recovery can as far as I know be evaluated without the use of a calibration curve and without regulators bashing you. I am thinking there is no harm in injecting the curve, but it isn't particularly informative if the QCs pass on it in those cases. That a run is approved by way of QC's does not necessarily imply that the run is qualified for a type of experiment that does not hinge on analyte divided by internal standard.
For stabilities I think you have often a plain injection of the curve. Hence you inject QC's in such runs.
Matrix effect and recovery can as far as I know be evaluated without the use of a calibration curve and without regulators bashing you. I am thinking there is no harm in injecting the curve, but it isn't particularly informative if the QCs pass on it in those cases. That a run is approved by way of QC's does not necessarily imply that the run is qualified for a type of experiment that does not hinge on analyte divided by internal standard.
For stabilities I think you have often a plain injection of the curve. Hence you inject QC's in such runs.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- bioanalytical validation runs samar sameh 2017-12-21 08:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- QCs in all runs Helmut 2017-12-21 14:53
- bioanalytical validation runsElMaestro 2017-12-21 17:30
- bioanalytical validation runs xtianbadillo 2018-01-18 15:31
Ing. Helmut Schütz