Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
The purpose of this study is to conduct a retrospective data analysis for inter-laboratory cross-validation studies to set a reasonable and practical acceptance criterion based on a number of cross-validation results. From the results of cross-validation studies for 16 compounds and their metabolites, analytical bias and variation were evaluated. The accuracy of cross-validation samples was compared with that of quality control (QC) samples with statistical comparison of the analytical variation. An acceptance criterion was derived with a confidential interval approach. As the results, while a larger bias was observed for the cross-validation samples, the bias was not fully caused by analytical variation or bias attributable to the analytical methods. The direction of the deviation between the cross-validation samples and QC samples was random and not concentration-dependent, suggesting that inter-laboratory variability such as preparation errors could be a source of bias. A derived acceptance criterion corresponds to one prescribed in the Guideline on bioanalytical method validation from the Ministry of Health, Labour and Welfare in Japan and is a little wider than one in the European Medical Agency. In conclusion, thorough retrospective data analysis revealed potential causes of larger analytical bias in inter-laboratory cross-validation studies. A derived acceptance criterion would be practical and reasonable for the inter-laboratory cross-validation study.
Authors and Affiliations
Tomoki Yoneyama, Takashi Kudo, Fumihiro Jinno, Eric R. Schmidt, Takahiro Kondo
Keywords
Related Articles
- EP ID EP681730
- DOI 10.1208/s12248-014-9653-0
- Views 87
- Downloads 0
Predicting when Biliary Excretion of Parent Drug is a Major Route of Elimination in Humans
The online version of this article (doi:10.1208/s12248-014-9636-1) contains supplementary material, which is available to authorized users.
Herb–Drug Interactions with St John’s Wort (Hypericum perforatum): an Update on Clinical Observations
St John’s wort (SJW) extracts, prepared from the aerial parts of Hypericum perforatum, contain numerous pharmacologically active ingredients, including naphthodianthrones (e.g., hypericin and its derivatives), ph...
Stable Isotope Dilution Mass Spectrometry for Membrane Transporter Quantitation
This review provides an introduction to stable isotope dilution mass spectrometry (MS) and its emerging applications in the analysis of membrane transporter proteins. Various approaches and application examples, for the...
Evaluation of the potential use of poly(ethylene oxide) as tablet- and extrudate-forming material
The purpose of this study was to assess the potential use of poly(ethylene oxide) (PEO) as matrix-forming mate-rial for tablets and extrudates. Raw materials were characterized for size, size distribution, and shape. Tab...
Microcalorimetric Method to Assess Phagocytosis: Macrophage-Nanoparticle Interactions
The online version of this article (doi:10.1208/s12248-010-9240-y) contains supplementary material, which is available to authorized users.