The application of control charts in regulated bioanalysis for monitoring long-term reproducibility. (December 2017)

• Record Type: Journal Article
• Authors: Bruijnsvoort, Michel van; Meijer, John; den Beld, Cas van
• Is Part Of: Bioanalysis. Volume 9:Number 24(2017)
• Page Start: 1955
• Page End: 1965
• Publication Date: 2017-12
• Subjects: β-NGF -- biomarker -- control chart -- GLP -- hepcidin -- long-term reproducibility -- PD -- PK -- regulated bioanalysis -- robustness; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2017-0163
• Languages: English
• ISSNs: 1757-6180

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.