Development and validation of an ELISA to study panitumumab pharmacokinetics

被引：4

作者：

Desvignes, Celine ^{[1
,2
]}

Passot, Christophe ^{[1
,2
]}

Ternant, David ^{[1
,2
]}

Caulet, Morgane ^{[3
]}

Guerineau, Caroline ^{[1
,2
]}

Lecomte, Thierry ^{[1
,3
]}

Paintaud, Gilles ^{[1
,2
]}

机构：

[1] Univ Francois Rabelais Tours, CNRS UMR GICC 7292, Tours, France

[2] CHRU Tours, Dept Pharmacol & Toxicol, Tours, France

[3] CHRU Tours, Dept Gastroenterol, Tours, France

来源：

BIOANALYSIS | 2018年 / 10卷 / 04期

关键词：

ELISA; monoclonal antibody; panitumumab; pharmacokinetics; therapeutic drug monitoring; RECEPTOR MONOCLONAL-ANTIBODY; LINKED-IMMUNOSORBENT-ASSAY; PROGRESSION-FREE SURVIVAL; LIGAND-BINDING ASSAYS; COLORECTAL-CANCER; SOLID TUMORS; ABX-EGF; CETUXIMAB; ASSOCIATION; MONOTHERAPY;

D O I：

10.4155/bio-2016-0292

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Aim: Panitumumab is a monoclonal antibody directed against EGFR that is approved for the treatment of metastatic colorectal cancer. To investigate its pharmacokinetics and concentration- response relationship, a validated assay is required. Results: An ELISA assay was developed and validated according to international recommendations. Six calibrators (ranging from 0.1 to 20 mg/l) plus one anchor point (50mg/l) and three quality controls (0.45, 2 and 8 mg/l) were defined. The limit of detection, lower limit of quantification and upper limit of quantification were 0.033, 0.112 and 10mg/l, respectively. Conclusion: This method is validated and can be used to study pharmacokinetics of panitumumab or to perform therapeutic drug monitoring.

引用

页码：205 / 214

页数：10

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