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@ARTICLE{Fresnais:157171,
      author       = {M. Fresnais$^*$ and A. Roth and K. I. Foerster and D.
                      Jäger and S. M. Pfister$^*$ and W. E. Haefeli and J.
                      Burhenne and R. Longuespée},
      title        = {{R}apid and {S}ensitive {Q}uantification of {O}simertinib
                      in {H}uman {P}lasma {U}sing a {F}ully {V}alidated
                      {MALDI}-{IM}-{MS}/{MS} {A}ssay.},
      journal      = {Cancers},
      volume       = {12},
      number       = {7},
      issn         = {2072-6694},
      address      = {Basel},
      publisher    = {MDPI},
      reportid     = {DKFZ-2020-01451},
      pages        = {E1897},
      year         = {2020},
      abstract     = {The third-generation tyrosine kinase inhibitor (TKI),
                      osimertinib, has revolutionized the treatment of patients
                      with non-small cell lung carcinoma with epidermal growth
                      factor receptor (EGFR)-activating mutation, and resistant to
                      first- and second-generation TKIs. Osimertinib is now also
                      proposed as a first-line therapy, thus extending the scope
                      of applications in lung oncology. Personalized medicine
                      approaches are still necessary to monitor if patients are
                      exposed to adequate concentrations of osimertinib during
                      their treatment. It would also help to understand the
                      appearance of new resistances in patients after several
                      months of dosing with osimertinib. Liquid
                      chromatography-tandem mass spectrometry (LC-MS/MS) is
                      currently the gold standard for the quantification of drugs
                      in plasma enabling pharmacokinetic analyses and patient
                      monitoring. In the present study, we propose an alternative
                      to LC-MS/MS methods for the rapid and sensitive
                      quantification of osimertinib in plasma using
                      matrix-assisted laser desorption/ionization (MALDI) -MS. The
                      presented assay requires only 3 min per sample for their
                      preparation, analysis, and data extraction, and less than 3
                      h for quantification. A lower limit of quantification (LLOQ)
                      of 5 ng/mL in plasma was retrieved. The method was fully
                      validated, following the guidelines of the US Food and Drug
                      Administration (FDA) and the European Medicines Agency (EMA)
                      for bioanalytical method validation. The present
                      developments prove the importance to consider alternative MS
                      assays for time-efficient quantification of small molecule
                      inhibitors in plasma in the context of personalized medicine
                      for targeted therapies.},
      cin          = {HD01 / B062},
      ddc          = {610},
      cid          = {I:(DE-He78)HD01-20160331 / I:(DE-He78)B062-20160331},
      pnm          = {312 - Functional and structural genomics (POF3-312)},
      pid          = {G:(DE-HGF)POF3-312},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32674434},
      doi          = {10.3390/cancers12071897},
      url          = {https://inrepo02.dkfz.de/record/157171},
}