Journal ArticleDOI
Advances in validation, risk and uncertainty assessment of bioanalytical methods.
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TLDR
Several essential aspects of methods validation, not only restricted to chromatographic ones but also to ligand binding assays owing to their increasing role in biopharmaceutical industries are discussed and highlighted.About:
This article is published in Journal of Pharmaceutical and Biomedical Analysis.The article was published on 2011-06-25. It has received 132 citations till now. The article focuses on the topics: Multiple-criteria decision analysis.read more
Citations
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The Statistical Analysis, of Experimental Data: A Fresh Approach Employing a Graphical Method for Investigating Non‐Normal Frequency Distributions
TL;DR: The introduction of statistical methods into the analysis of aeronautical experimental data, whether for quality control in production, for the interpretation of the results of structural and aerodynamic laboratory experiments, or for airline operation, has been brought about only in recent years, it may by now be fair to assert that their advantages are no longer in dispute.
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Tutorial review on validation of liquid chromatography-mass spectrometry methods: part II.
Anneli Kruve,Riin Rebane,Karin Kipper,Maarja-Liisa Oldekop,Hanno Evard,Koit Herodes,Pekka Ravio,Ivo Leito +7 more
TL;DR: This is the part II of a tutorial review intending to give an overview of the state of the art of method validation in liquid chromatography mass spectrometry and discuss specific issues that arise with MS (and MS-MS) detection in LC (as opposed to the "conventional" detectors).
Journal ArticleDOI
Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect.
Oskar González,María Encarnación Blanco,Gorka Iriarte,L. Bartolomé,M.I. Maguregui,Rosa M. Alonso +5 more
TL;DR: The overall validation process including common validation parameters (selectivity, linearity range, precision, accuracy, stability…) will be reviewed, the most controversial parameters (limit of quantification, robustness and matrix effect) will be carefully studied and the definitions and methodology proposed by the different regulatory bodies will be compared.
Journal ArticleDOI
Quality by design approach: Regulatory need
TL;DR: In this paper, a review of the QbD approach, its historical background, and regulatory needs are discussed, in detail explanation of elements of QdD i.e. method intent, design of experiment, and risk assessment is given.
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Design Spaces for analytical methods
TL;DR: This article aims to explain what an analytical method DS is, why it is useful for the robust development and optimization of analytical methods and how to build such a DS.
References
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Journal ArticleDOI
An Analysis of Transformations
George E. P. Box,David Cox +1 more
TL;DR: In this article, Lindley et al. make the less restrictive assumption that such a normal, homoscedastic, linear model is appropriate after some suitable transformation has been applied to the y's.
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Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS.
TL;DR: Practical, experimental approaches for studying, identifying, and eliminating the effect of matrix on the results of quantitative analyses by HPLC-MS/MS are described and it is demonstrated that, for the investigational drug under study, the matrix effect was clearly observed when ISP interface was utilized but it was absent when the HN interface was employed.
Book ChapterDOI
International Organization for Standardization ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
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Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)
TL;DR: In this article, the Working Group that produced these protocols/guidelines has now been mandated by IUPAC to prepare guidelines on the single-laboratory validation of methods of analysis, providing minimum recommendations on procedures that should be employed to ensure adequate validation of analytical methods.