Lee Goodwin, Jörg Faber, Kristina H Holmberg, Stuart McDougall, John Meijer, Debora Tagliacozzi, Stephen White, Philip Timmerman
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引用次数: 0
Abstract
This paper discusses the updated recommendations from the European Bioanalysis Forum on whole blood stability testing in bioanalytical method validation. The recommendations are based on EBF community feedback on the ICH M10 guidelines and associated training materials. The ICH M10 guidelines highlight the importance of assessing analyte stability throughout the lifecycle of the sample, including in whole blood, immediately after collection, to ensure that the analyte concentration in the tested sample accurately reflects the concentration at the time of collection. Aspects considered in these recommendations are the definition of fresh blood, equilibration times, assay type and how the experiments can be conducted to align with the 3Rs principles.
BioanalysisBIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL
CiteScore
3.30
自引率
16.70%
发文量
88
审稿时长
2 months
期刊介绍：
Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing.
The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality.
Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing.
The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques.
Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
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