EBF recommendation on the validation of bioanalytical methods for dried blood spots
EBF recommendation on the validation of bioanalytical methods for dried blood spots
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DOI：
10.4155/bio.11.132
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发表时间：
2011-07-01
期刊：
影响因子：
1.8
通讯作者：
Smeraglia, John
中科院分区：
文献类型：
--
作者：
Timmerman, Philip;White, Steve;Smeraglia, John
在过去的几年里，生物分析学家、药物动力学家和临床研究人员重新发现了干血点技术。这种复兴为制药研发提供了丰富的机会，可以优化药物发现和开发过程，包括动物和患者伦理、新的科学见解和成本节约。在生物分析方面，已经进行了多次实验，并获得了许多经验。然而，这项技术仍然面临许多生物分析方面的挑战。欧洲生物分析论坛讨论了该技术的优势和障碍，并在一份关于干血斑生物分析方法验证的建议中总结了他们目前的想法，这可以作为进一步讨论和实验的基石。
Over the last few years bioanalysts, pharmacokineticists and clinical investigators have rediscovered the technique of dried blood spots. The revival has provided pharmaceutical R&D a wealth of opportunities to optimize the drug-discovery and development process with respect to animal and patient ethics, new scientific insights and costs savings. On the bioanalytical front, multiple experiments have been performed and a lot of experience has been gained. Nevertheless, the technique still has a number of bioanalytical challenges. The European Bioanalysis Forum discussed the advantages and hurdles of the technique and summarized their current thinking in a recommendation on the validation of bioanalytical methods for dried blood spots, which can be used as a cornerstone for further discussions and experiments.