6th Annual Bioanalysis in Clinical Research conference

被引:0
|
作者
Silvester, Steve [1 ]
Cook, Jason [2 ]
机构
[1] AstraZeneca R&D Charnwood, Clin Pharmacol & DMPK, Loughborough LE11 5RH, Leics, England
[2] AstraZeneca R&D Charnwood, Personalised Healthcare & Biomarkers, Loughborough LE11 5RH, Leics, England
关键词
D O I
10.4155/BIO.11.94
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The 6th Annual Bioanalysis in Clinical Research conference held recently in London, UK, targeted numerous themes of significant current interest within the discipline of bioanalysis. The conference invited a diverse speaker panel and attracted an audience consisting of researchers from the pharmaceutical industry, CROs and academia. The range of topics presented covered LC-MS and ligand-binding assays, small-and large-molecule quantification, regulatory issues and concerns and new technologies. Within the scope of LC-MS bioanalysis, presentation topics included new developments in dried blood spot technologies, the use of direct ana-lysis MS techniques, eliminating matrix effects through direct-electron ionization MS, and the complications of developing and validating LC-MS methods for the quantitative determination of endogenous biomarkers. With respect to ligand binding, the importance of assay validation being a continuous process, extending into study ana-lysis, was a recurrent theme in several presentations along with the hot topic of immunogenicity. Of relevance to both analytical disciplines were the presentations on regulatory topics covering the EMA guidelines on method validation and bioanalysis within bioequivalence clinical studies.
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页码:1061 / 1063
页数:3
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