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- W2894770035 abstract "Abstract Background The application of liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) represents one of the most compelling opportunities for advancements in human health through the combination of reference measurement procedure capabilities, broad chemical coverage, and a rich history in support of drug development from the 1990s onward. Clinical application of these technologies has begun to gather pace in many laboratories, with diverse applications ranging from expanded newborn screening to identification of emerging toxicants. The promise of these technologies is vast and the need is palpable; however, the journey can be exacting. Perhaps somewhat unique among analytical techniques, LC-MS/MS assay development and validation requires significant knowledge of a number of specialties: a mastery of chemistry (sample preparation, chromatography, ionization), physics (ion manipulation), engineering principles (automation, order of experiments, programming), and mathematics (data reduction and interpretation) applied to questions of a biological origin (normal, disease, metabolism). Content This chapter provides a stepwise roadmap for systematically developing and validating an LC-MS/MS assay for small molecule analytes. Starting from first principles (salt correction in gravimetric weighing), each component of the LC-MS/MS assay (mass spectrometer tuning, ionization enhancements, chromatography, extraction) is detailed with best-practice experiments for development and data reduction techniques to fulfill performance goals. After refinement of each component of the assay, prevalidation experiments are described to enable efficient execution of validation. Finally, an array of validation guidance documents is reduced to a coherent process for burden of proof." @default.
- W2894770035 created "2018-10-12" @default.
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- W2894770035 date "2018-01-01" @default.
- W2894770035 modified "2023-09-25" @default.
- W2894770035 title "Development and Validation of Small Molecule Analytes by Liquid Chromatography-Tandem Mass Spectrometry" @default.
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- W2894770035 doi "https://doi.org/10.1016/b978-0-12-816063-3.00005-0" @default.
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