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- W1514405905 abstract "The proper use of statistical techniques in bioanalytical method development, validation, and monitoring is a key tool for ensuring adequate method performance. This chapter presents an overview of basic statistical concepts and the application of statistical techniques to address selected issues in bioanalytical method development, validation, and monitoring. Basic concepts and formulae are provided for regression analysis and analysis of variance (ANOVA) techniques, which form the basis for many statistical approaches to evaluating bioanalytical method performance. Criteria and statistical techniques for selection of an appropriate calibration function and weighting factor are described. A total error approach for evaluating method bias and precision is detailed. Various regression techniques for the assessment of long-term analyte stability are compared. A statistical tolerance interval approach for the evaluation of incurred sample reproducibility (ISR) is presented. Examples are provided to illustrate the application of each statistical technique." @default.
- W1514405905 created "2016-06-24" @default.
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- W1514405905 date "2013-08-30" @default.
- W1514405905 modified "2023-10-14" @default.
- W1514405905 title "LC‐MS Bioanalysis‐Related Statistics" @default.
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- W1514405905 doi "https://doi.org/10.1002/9781118671276.ch32" @default.
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