The road to reliable peptide assays is paved with good guidelines.

Clinical endocrinology(2022)

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摘要
Kowalka et al. recently validated a new Liquid Chomatography Tandem Mass Spectrometry (LC-MS/MS) assay for PYY1-36 and PYY3-36 in human plasma using three different guidelines: the 2018 Food and Drug Administration (FDA) guideline for bioanalytical method validation, the 2014 Clinical and Laboratory Standards Institute (CLSI) C62-A guideline, and the penultimate 2011 European Medicines Agency (EMA) guideline on bioanalytical method validation updated in 2015 This article is protected by copyright. All rights reserved.
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关键词
LLOQ values,clinical studies,data processing,guidelines,matrix effect,peptide assays,stability
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