Determination of osimertinib in human plasma, urine and cerebrospinal fluid

被引：14

作者：

Mitchell, Richard ^{[1
]}

Bailey, Christopher ^{[2
]}

Ewles, Matthew ^{[1
]}

Swan, Gordon ^{[1
]}

Turpin, Phillip ^{[1
]}

机构：

[1] Covance Labs, Harrogate, England

[2] AstraZeneca R&D, Cambridge, England

来源：

BIOANALYSIS | 2019年 / 11卷 / 10期

关键词：

adsorption; AZD9291; cross-validation; CSF; ISR; LC-MC; MS; osimertinib; plasma; Tagrisso; urine; EGFR; AZD9291;

D O I：

10.4155/bio-2018-0262

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Aim: Osimertinib (Tagrisso, AZD9291) has been approved for the treatment of patients with metastatic EGFRm T790M non-small-cell lung cancer. Results: Rapid and sensitive LC-MC/MS methods were developed for osimertinib and its metabolites, AZ13597550 and AZ13575104, in human plasma (low- and high-range), urine and cerebrospinal fluid. We discuss the challenges of these multi-analyte and multiple matrix assays. The methods have been successfully validated and used for the analysis of over 20,000 clinical samples, with successful incurred sample reproducibility. Conclusion: The assays have been shown to be selective, accurate and robust, providing high-throughput analysis during the clinical development of osimertinib.

引用

页码：987 / 1001

页数：15

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