Tuyển tập các báo cáo nghiên cứu về hóa học được đăng trên tạp chí sinh học quốc tế đề tài : Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist | Journal of Translational Medicine BioMed Central Open Access Methodology Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist Timothy Wyant 1 Alan Lackey2 3 and Marie Green1 Address Millennium Pharmaceuticals Cambridge MA USA 2Esoterix Center for Clinical Trials Brentwood TN USA and 3Nodality Inc. Brentwood TN USA Email Timothy Wyant - wyant@ Alan Lackey - alackey@ Marie Green - Corresponding author Published I December 2008 Received 3 September 2008 _ -T_-mno J .in IIOZ IZTO roi z - z Accepted 1 December 2008 Journal of Translational Medicine 2008 6 76 doi 1479-5876-6-76 This article is available from http content 6 1 76 2008 Wyant et al licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http licenses by which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Abstract Pharmacodynamic assays are important in clinical trial design to investigate the relationship between drug concentration pharmacokinetics and drug effect or biological activity. Increasingly flow cytometry is being used to examine the pharmacodynamic effect of new drug entities. However to date the analytical validation of cytometry based assays is limited and there is no suitable guidance for method validation of flow cytometry-based pharmacodynamic assays. Here we report the validation of a flow cytometry-based chemokine internalization assay for use in evaluating the effect of a receptor antagonist in clinical trials. The assay method was validated by examining the stability of the reagent assay robustness sensitivity repeatability and reproducibility precision. Experimental results show the assay reagent was stable over 26 weeks. The assay demonstrated
