The flow beads array assay as an efficacy assessment of a clinical trial

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  • 「臨床試験の有効性評価としてのビーズアレイ」

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Abstract

<p>Recently, Pharmacogenomics and Pharmacodynamics are performed in clinical trials. However, the quality and quantity of those pharmacodynamic evaluations is not sufficient. Especially, the cytokine evaluation methods must be adequately constructed as soon as possible in order to avoid the adverse-reaction accident,which was unfortunately happened in the phase I trial performed in Britain in March, 2006. Therefore, we examined the new cytokine evaluation method which uses the flow beads array assay for the pharmacodynamic evaluation. We stimulated peripheral blood mononuclear cells(PBMC) collected from 4 healthy volunteers and 4 allergic patients with Japanese cedar pollen, and then measured those cytokines production with Enzyme Linked Immunosorbent Assay (ELISA) and the flow beads array assay. Th2 cytokines production was detected from PBMC from allergic patients with Japanese cedar pollen after antigen-specific stimulation for 7 days. Th2 cytokines could not be detected from PBMC from healthy volunteers. The results of ELISA and the flow beads array assay on cytokines production were closely correlated. We confirmed that the flow beads array analysis is beneficial for the evaluation of clinical trials in its cost performance and operation efficiency.</p>

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