The application of control charts in regulated bioanalysis for monitoring long-term reproducibility
| Autor: | John Meijer, Cas van den Beld, Michel van Bruijnsvoort |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Quality Control
Bioanalysis Computer science Clinical Biochemistry 030226 pharmacology & pharmacy 01 natural sciences Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Hepcidins Limit of Detection Nerve Growth Factor Humans Control chart General Pharmacology Toxicology and Pharmaceutics Reproducibility Heparin 010401 analytical chemistry Reproducibility of Results General Medicine Decision rule 0104 chemical sciences Term (time) Reliability engineering Medical Laboratory Technology Algorithms Biomarkers Half-Life |
| Zdroj: | Bioanalysis. 9(24) |
| ISSN: | 1757-6199 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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