Hecht Max, Veigure Rūta, Couchman Lewis, S Barker Charlotte I, Standing Joseph F, Takkis Kalev, Evard Hanno, Johnston Atholl, Herodes Koit, Leito Ivo, Kipper Karin
Chair of Analytical Chemistry, Institute of Chemistry, University of Tartu, 14a Ravila Street, 50411 Tartu, Estonia.
Analytical Services International, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK.
Bioanalysis. 2018 Aug 1;10(15):1229-1248. doi: 10.4155/bio-2018-0078. Epub 2018 Jul 23.
Traditionally, bioanalytical laboratories do not report actual concentrations for samples with results below the LOQ (BLQ) in pharmacokinetic studies. BLQ values are outside the method calibration range established during validation and no data are available to support the reliability of these values. However, ignoring BLQ data can contribute to bias and imprecision in model-based pharmacokinetic analyses. From this perspective, routine use of BLQ data would be advantageous. We would like to initiate an interdisciplinary debate on this important topic by summarizing the current concepts and use of BLQ data by regulators, pharmacometricians and bioanalysts. Through introducing the limit of detection and evaluating its variability, BLQ data could be released and utilized appropriately for pharmacokinetic research.
传统上，生物分析实验室在药代动力学研究中不会报告结果低于定量下限（BLQ）的样本的实际浓度。BLQ值超出了验证期间建立的方法校准范围，并且没有数据可支持这些值的可靠性。然而，忽略BLQ数据可能会导致基于模型的药代动力学分析出现偏差和不精确。从这个角度来看，常规使用BLQ数据将是有利的。我们希望通过总结监管机构、药物计量学家和生物分析师目前对BLQ数据的概念和使用情况，就这个重要话题展开跨学科辩论。通过引入检测限并评估其变异性，BLQ数据可以被释放并适用于药代动力学研究。
