Receptor occupancy measurement of anti-PD-1 antibody drugs in support of clinical trials

Receptor occupancy measurement of anti-PD-1 antibody drugs in support of clinical trials
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DOI:
10.4155/bio-2019-0090
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发表时间:
2019-07-01
期刊:
影响因子:
1.8
通讯作者:
Song, Hai-Feng
Song, Hai-Feng
中科院分区:
医学4区
文献类型:
--
作者:
Fu, Jie;Wang, Fang;Song, Hai-Feng

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Aim: The reliable measurement of receptor occupancy (RO) provides informative data for efficacy and safety evaluation. This study aimed to assess factors affecting RO measurement of anti-PD-1 antibodies in clinical studies. Materials & methods: RO performance was assessed using different T-cell activation markers measured by flow cytometry. The validated methodology was then used in support of a clinical study. Results: The optimized active cell population was comprised of CD45RO(+) or CD45RA(-) T cells. The bioanalytical method was validated for inter- and intra-assay precision (coefficient of variation