Bioanalytical methods for therapeutic monoclonal antibodies using selective separation technique
Project/Area Number |
25460040
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Research Category |
Grant-in-Aid for Scientific Research (C)
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Allocation Type | Multi-year Fund |
Section | 一般 |
Research Field |
Physical pharmacy
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Research Institution | University of Shizuoka |
Principal Investigator |
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Co-Investigator(Kenkyū-buntansha) |
Hayashi Hideki 岐阜薬科大学, 薬学部, 准教授 (00419665)
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Project Period (FY) |
2013-04-01 – 2016-03-31
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Project Status |
Completed (Fiscal Year 2015)
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Budget Amount *help |
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2015: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2014: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2013: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
|
Keywords | 抗体医薬 / HPLC分析 / 血中薬物濃度分析 / LC/MS/MS |
Outline of Final Research Achievements |
In this study, we developed a simple, sensitive, accurate, and rapid analytical method for detecting therapeutic monoclonal antibodies in plasma samples using immunoaffinity purification e HT-RPLC with fluorescence detection. We successfully applied both methods to the bioanalyses of plasma samples obtained from cancer and RA patients who were administered each drug. The methods described here are applicable for planning optimal therapeutic programs, and also for the evaluation of biological equivalencies in the development of biosimilars.
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Report
(4 results)
Research Products
(74 results)
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[Journal Article] Bioanalysis of bevacizumab and infliximab by high-temperature reversed-phase liquid chromatography with fluorescence detection after immunoaffinity magnetic purification2016
Author(s)
K. Todoroki, T. Nakano, Y. Eda, K. Ohyama, H. Hayashi , D. Tsuji, J.Z. Min, K. Inoue, N. Iwamoto, A. Kawakami, Y. Ueki, K. Itoh, T. Toyo'oka
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Journal Title
Anal. Chim. Acta
Volume: 916
Pages: 112-119
DOI
Related Report
Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
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[Journal Article] An easy-to-use excimer fluorescence derivatization reagent, 2-chloro-4-methoxy-6-(4-(pyren-4-yl)butoxy)-1,3,5-triazine, for use in the highly sensitive and selective liquid chromatography analysis of histamine in Japanese soy sauces2015
Author(s)
T. Nakano, K. Todoroki, Y. Ishii, C. Miyauchi, A. Palee, J.Z. Min, K. Inoue, K. Suzuki, T. Toyo’oka
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Journal Title
Anal. Chim. Acta
Volume: 880
Pages: 145-151
DOI
Related Report
Peer Reviewed / Acknowledgement Compliant
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[Journal Article] Towards the chiral metabolomics: Liquid chromatography-mass spectrometry based DL-amino acid analysis after labeling with a new chiral reagent, (S)-2,5-dioxopyrrolidin-1-yl-1-(4,6-dimethoxy-1,3,5-triazin-2-yl)pyrrolidine-2-carboxylate, and the application to saliva of healthy volunteers2015
Author(s)
Toshiki Mochizuki, Takahiro Takayama, Kenichiro Todoroki, Koichi Inoue, Jun Zhe Min, Toshimasa Toyo'oka
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Journal Title
Analytica Chimica Acta
Volume: 875
Pages: 73-82
DOI
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Peer Reviewed / Acknowledgement Compliant
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[Journal Article] Human nails metabolite analysis: A rapid and simple method for quantification of uric acid in human fingernail by high-performanceliquid chromatography with UV-detection2015
Author(s)
Xi-Ling Li, Gao Li, Ying-Zi Jiang, Dongzhou Kang, Cheng Hua Jin, Qing Shi,Toufeng Jin, Koichi Inoue, Kenichiro Todoroki, Toshimasa Toyo'oka, Jun Zhe Min
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Journal Title
Journal of Chromatography B
Volume: 1002
Pages: 394-398
DOI
Related Report
Peer Reviewed / Int'l Joint Research / Acknowledgement Compliant
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[Journal Article] Simple and sensitive analysis of histamine and tyramine in Japanese soy sauces and their intermediates using the stable isotope dilution HILIC–MS/MS method.2014
Author(s)
Todoroki, K., Ishii, Y., Miyauchi, C., Kitagawa, S., Min, J. Z., Inoue, K., Yamanaka, T., Suzuki, K., Yoshikawa, Y., Ohashi, N. and Toyo'Oka, T.
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Journal Title
Journal of Agricultual Food Chemistry
Volume: 62
Issue: 26
Pages: 6206-6211
DOI
Related Report
Peer Reviewed
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[Journal Article] Assessment of the Efficacy of Anticancer Drugs by Amino Acid Metabolomics Using Fluorescence Derivatization-HPLC2014
Author(s)
Ryoko Tomita, Kenichiro Todoroki, Kazuyuki Machida, Sho Nishida, Hiroshi Maruoka, Hideyuki Yoshida, Toshihiro Fujioka, Manabu Nakashima, Masatoshi Yamaguchi, Hitoshi Nohta
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Journal Title
Analytical Sciences
Volume: 30
Issue: 7
Pages: 751-758
DOI
NAID
ISSN
0910-6340, 1348-2246
Related Report
Peer Reviewed / Open Access
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[Journal Article] Simultaneous microdetermination of bosentan, ambrisentan, sildenafil, and tadalafil in plasma using liquid chromatography/tandem mass spectrometry for pediatric patients with pulmonary arterial hypertension.2014
Author(s)
Y. Yokoyama, M. Tomatsuri, H. Hayashi, K. Hirai, Y. Ono, Y. Yamada, K. Todoroki, T. Toyo’oka, H. Yamada, K. Itoh
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Journal Title
J. Pharm. Biomed. Anal.
Volume: 89
Pages: 227-232
DOI
Related Report
Peer Reviewed
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[Journal Article] UPLC/ESI-MS/MS-based determination of metabolism of several new illicit drugs, ADB-FUBINACA, AB-FUBINACA, AB-PINACA, QUPIC, 5F-QUPIC and α-PVT, by human liver microsome.2014
Author(s)
T. Takayama, M. Suzuki, K. Todoroki, K. Inoue, J.-Z. Min, R. Kikura-Hanajiri, Y. Goda, T. Toyo'oka
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Journal Title
Biomed. Chromatogr.
Volume: 28
Issue: 6
Pages: 831-838
DOI
Related Report
Peer Reviewed
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[Journal Article] In vivo imaging of reactive oxygen species in mouse brain by using [3H]Hydromethidine as a potential radical trapping radiotracer.2014
Author(s)
K. Abe, N. Takai, K. Fukumoto, N. Imamoto, M. Tonomura, M. Ito, N. Kanegawa, K. Sakai, K. Morimoto, K. Todoroki, O. Inoue
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Journal Title
J. Cereb. Blood Flow Metab.
Volume: 34
Issue: 12
Pages: 1907-1913
DOI
Related Report
Peer Reviewed
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[Journal Article] Evaluation of gardenia yellow using crocetin from alkaline hydrolysis based on ultra high performance liquid chromatography and high-speed countercurrent.2014
Author(s)
K. Inoue, C. Tanada, H. Nishikawa, S. Matsuda, A. Tada, Y. Ito, J.-Z. Min, K. Todoroki, N. Sugimoto, T. Toyo'oka, H. Akiyama
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Journal Title
J. Sep. Sci.
Volume: 37
Issue: 24
Pages: 3619-3624
DOI
Related Report
Peer Reviewed
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[Presentation] Separation behavior characterization of therapeutic monoclonal antibody preparations by high-temperature reversed-phase LC using wide pore core-shell column.2013
Author(s)
Kenichiro Todoroki, Atsuko Nakane, Koji Toyoda, Yuki Sato, Hideki Hayashi, Tsutomu Kai, Jun Zhe Min, Koichi Inoue, Shinobu Kudoh, Kunihiko Itoh, Toshimasa Toyo’oka:
Organizer
The 40th International Symposium on High Performance Liquid Phase Separations and Related Techniques
Place of Presentation
Tasmania
Related Report
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