| Item type |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2021-01-05 |
| タイトル |
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|
タイトル |
抗体医薬のTDMの普及を志向したヒト血清中濃度測定の分析ワークフローの構築 |
|
言語 |
ja |
| タイトル |
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|
タイトル |
Construction of quantitative analysis workflow for determination of serum concentrations of monoclonal antibody drugs aiming to promote therapeutic drug monitoring in clinical practice |
|
言語 |
en |
| 言語 |
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|
言語 |
jpn |
| キーワード |
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|
主題 |
monoclonal antibody drug |
| キーワード |
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|
主題 |
LC-MS/MS |
| キーワード |
|
|
主題 |
therapeutic drug monitoring |
| キーワード |
|
|
主題 |
pharmacokinetics |
| 資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 著者 |
内藤, 隆文
柴田, 海斗
志田, 拓顕
阿部, 一樹
川上, 純一
|
| 書誌情報 |
臨床薬理
en : Japanese Journal of Clinical Pharmacology and Therapeutics
巻 51,
号 3,
p. 161-166,
発行日 2020-05-31
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| 出版者 |
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|
出版者 |
日本臨床薬理学会 |
| 権利 |
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|
権利情報 |
Copyright 日本臨床薬理学会 |
| 権利 |
|
|
権利情報 |
日本臨床薬理学会の許諾を得て登録 |
| 抄録 |
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|
内容記述タイプ |
Abstract |
|
内容記述 |
Although ligand binding assays are commonly used for the determination of serum concentrations of monoclonal antibody drugs in humans, the serum concentrations measured by these assays are potentially increased by cross-reaction with endogenous proteins and decreased by the presence of neutralizing antibodies. Recently, proteomic approaches using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) have been employed for the measurement of monoclonal antibody drugs in human specimens. For serum concentrations of monoclonal antibody drugs, the proteomic approaches require complicated pretreatment processes including immunopurification, denaturation, reduction, alkylation, tryptic digestion, desalination, clean-up, and reconstitution. These pretreatment processes are time-consuming and potentially cause analytical variations. To date, the proteomic approaches using LC-MS/MS methods have not been fully applied to clinical practice. We have constructed quantitative analysis workflow that uses a signature peptide selected by Fourier transform mass spectrometer to ensure its uniqueness in human serum, extracts serum immunoglobulins with immobilized Protein G to reduce the matrix effect if needed, and employs immobilized trypsin for rapid protein digestion. The entire pretreatment and quantitation using the present LC-MS/MS method can be completed within one day. Additionally, the analytical performance data obtained from these methods meet the standards of international guidance. The present report describes the construction of quantitative analysis workflow for measurement of monoclonal antibody drugs in human serum. Our approaches would contribute to promote therapeutic drug monitoring of monoclonal antibody drugs in clinical practice. |
| ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
0388-1601 |
| EISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
1882-8272 |
| 出版社DOI |
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関連タイプ |
isIdenticalTo |
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|
識別子タイプ |
DOI |
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関連識別子 |
10.3999/jscpt.51.161 |
| 著者版フラグ |
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出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
JJCPT-51-161.pdf (1.3 MB)
