bioanalytical validation runs [Bioanalytics]

posted by ElMaestro  – Denmark, 2017-12-21 18:30 (1922 d 00:24 ago) – Posting: # 18079
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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.

Pass or fail!

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