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Research Article

Clinical Development of Imatinib: an Anticancer Drug

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Article: FSO92 | Received 10 Dec 2015, Accepted 09 Dec 2015, Published online: 25 Jan 2016

References

  • Haouala A , ZanolarN, RochatB, MontemurroM, ZamanK, DuchosalMA. Therapeutic drug monitoring form the new targeted anticancer agents imatinib, nilotinib, dasatinib, sunitinib, sorafenib and lapatinib by LC tandem mass. J. Chromatogr. B877, 1982–1996 (2009).
  • Schmidli H , PengB, CapdevilleRet al. Population pharnacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukemia: results of a Phase III study. Br. J. Clin. Pharmacol.60, 35–44 (2005).
  • Nikolova Z , PengB, HubertMet al. Bioequivalence, safety and tolerability of imatinib tablets compared with capsules. Can. Chemother. Pharmacol.53, 433–438 (2004).
  • Huhuet F , GiocantiN, HennequinCet al. Growth inhibition by STI571 in combination with radiation in human chronic myelogenous leukemia K562 cells. Mol. Canc. Ther.7, 398–406 (2008).
  • Szczepek WJ , KosmacinskaB, BielejewskaAet al. Identification of imatinib mesylate degradation products obtained under stress conditions. J. Pharma. Biomed. Anal.43, 1682–1691 (2007).
  • Roth O , Spreux-VaroquauxO, bouchetSPet al. Imatinib assay by HPLC with photodiode-array UV detection in plasma from patients with chronic myeloid leukemia: comparision with LC-MS/MS. Clin. Chim. Acta411, 140–146 (2010).
  • Lugo TG , PendergastMA, MullerAJet al. Tyrosine kinase activity and transformation potency of bcr-abl oncogene products. Science247, 1079–1082 (1990).
  • Druker BJ , SawyersLC, KantarjianHet al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronicmyeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N. Engl. J. Med.344, 1038–1042 (2001).
  • Druker BJ , TalpazM, RestaJDet al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N. Engl. J. Med.3443, 1031–1037 (2001).
  • Kantarjian H , SawyersC, HochhausAet al. for the International STI571 CML Study Group: hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N. Engl. J. Med.346, 645–652 (2002).
  • Sawyers LC , HochhausA, FeldmanEet al. Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a Phase II study. Blood99, 3530–3539 (2002).
  • Talpaz M , SilverT, DrukerJBet al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a Phase 2 study. Blood99, 1928–1937 (2002).
  • Peng B , LloydP, SchranH. Clinical pharmacokinetics of imatinib. Clin. Pharmacol.44(8), 79–94 (2005).
  • Campiglia PS , ErcoliMC, UmpeirrezOet al. Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single dose, fasting, two-period, two-sequence crossover comparision in healthy male South American volunteers. Clin. Ther.31, 2224–2232 (2009).
  • Chahbouni J , den BurgerC, VosMRet al. Simultaneous quantification of erlotinib, gefitinib, and imatinib in human plasma by liquid chromatography tandem mass spectrometry. Ther. Drug Monit.31, 683 (2009).
  • Awidi A , SalemI, NajibNet al. Determination of imatinib plasma levels in patients with chronic myeloid leukemia by high performance liquid chromatography-ultraviolet detection and liquid chromatography-tandem mass spectrometry: methods’ comparison. Leuk. Res.34, 714 (2010).
  • Couchman L , BirchM, IrelandRet al. An automated method for the measurement of a range of tyrosine kinase inhibitors in human plasma or serum using turbulent flow liquid chromatography-tandem mass spectrometry. J. Anal. Bioanal. Chem.403, 1685 (2012).
  • Gotze L , HegeleA, MetzelderKSet al. Development and clinical application of a LC-MS/MS method for simultaneous determination of various tyrosine kinase inhibitors in human plasma. Clin. Chim. Acta413, 143 (2012).
  • Iqbal Z , ElliottM, WatsonGD, HolyoakeTet al. Analysis of imatinib in bone marrow and plasma samples of chronic myeloid leukaemia patients using solid phase extraction LC-ESI-MS. Pak. J. Pharm. Sci.24, 285 (2011).
  • Lankheet AN , HillebrandMJ, RosingHet al. Method development and validation for the quantification of dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, sorafenib and sunitinib in human plasma by liquid chromatography coupled with tandem mass spectrometry. Biomed. Chromatogr.27, 466–476 (2013).
  • Widmer N , BeguinA, RochatBet al. Determination of imatinib (Gleevec®) in human plasma by solid-phase extraction-liquid chromatography-ultrviolet absorbance detection. J. Chromatogr. B803, 285–292 (2004).
  • Draft guidance for industry: bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research and Centre for Veterinary Medicine, September 2013. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf.
  • European Medicines Agency . Guidance on bioanalytical method validation (2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  • Reckmann A , FisherHT, PengBet al. Effect of food on STI571 Glivec pharmacokinetics and bioavailability. Proc. Am. Soc. Clin. Oncol.20, Abstract 307a (2001).
  • European Medicines Agency. Guidance on imatinib product-specific bioequivalence guidance (2013). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500154317.pdf.
  • Solassol I , BressoleeF, CharassonVet al. Liquid chromatography-electrospray mass spectrometry determination of imatinib and its metabolite, N-desmethy- imatinib in human plasma. J. Liq. Chromatogr. Rel. Tech.29, 2957–2974 (2007).
  • Micova K , FriedeckyD, FaberEet al. Flow injection ana¬lysis vs. ultra high performance liquid chromatography coupled with tandem mass spectrometry for determination of imatinib in human plasma. Clin. Chim. Acta41, 11957–1962 (2010).