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Published on: March 17, 2023
The application of control charts in regulated bioanalysis for monitoring long-term reproducibility
Michel van Bruijnsvoort1, John Meijer1, Cas van den Beld1
1Astellas Pharma Europe B.V., Drug Development Research, Bioanalysis-Europe, Sylviusweg 62, 2333 BE Leiden, The Netherlands.
Abstract:
In regulated bioanalysis, the acceptance of results is batch-wise. When during clinical development derived pharmacokinetic or pharmacodynamic results from different studies will be combined or compared, it is recommendable to monitor the long-term reproducibility of bioanalytical assays. Long-term reproducibility can be evaluated by control charts generated from control samples included in each batch. We present a methodology for the implementation, construction and evaluation of control charts next to the regular batch acceptance of bioanalytical results. Decision rules can be set up for a statistical evaluation of the results. Violation of a decision rule may lead to a root-cause investigation and corrective actions to improve assay robustness. Three examples of control charts, for pharmacokinetic and pharmacodynamic analytes are presented.
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