548
Views
0
CrossRef citations to date
0
Altmetric
Methodology

Bioanalysis of Alectinib and Metabolite M4 in Human Plasma, Cross-Validation and Impact on PK Assessment

, , , , , , & show all
Pages 1465-1479 | Received 21 Mar 2016, Accepted 27 May 2016, Published online: 22 Jun 2016

References

  • Sakamoto H , TsukaguchiT, HiroshimaSet al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell19, 679–690 (2011).
  • Kodama T , TsukaguchiT, SatohYet al. Alectinib shows potent antitumor activity against RET-rearranged non-small cell lung cancer. Mol. Cancer Ther. 13, 2910–2918 (2014).
  • Kodama T , HasegawaM, TakanashiK, SakuraiY, KondohO, SakamotoH. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother. Pharmacol. 74, 1023–1028 (2014).
  • Seto T , KiuraK, NishioMet al. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, Phase 1–2 study. Lancet Oncol. 14, 590–98 (2013).
  • Takeuchi K , TogashiY, KamiharaY, FukuyamaT, YoshiokaHet al. Prospective and clinical validation of ALK immunohistochemistry: results from the Phase I/II study of alectinib for ALK-positive lung cancer (AF-001JP study). Ann. Oncol. 27 (1), 185–192 (2016).
  • Ou S-H , AhnJS, De PetrisLet al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a Phase II global study. J. Clin. Oncol. 34 (7), 661–668 (2016).
  • Shaw A , GandhiL, GadgeelS. Phase 2 study of alectinib in ALK-positive, crizotinib-resistant non-small-cell lung cancer. Lancet Oncol. 17 (2), 234–242 (2016).
  • Gandhi L , ShawA, GadgeelSet al. A Phase 2, open-label, multicenter study of the ALK inhibitor alectinib in an ALK+ non-small-cell lung cancer (NSCLC) US/Canadian population who had progressed on crizotinib (NP28761). J. Clin. Oncol. 33 (15), Abstract 8019 (2015).
  • Barlesi F , DingemansA-MC, OuS-HIet al. Updated efficacy and safety results from a global Phase 2, open-label, single-arm study (NP28673) of alectinib in crizotinib-refractory ALK+ non-small-cell lung cancer (NSCLC). Eur. J. Cancer51 (S3), Abstract 3101 (2015).
  • Gadgeel SM , GandhiL, RielyGJet al. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a Phase 1/2 study. Lancet Oncol. 15, 1119–1128 (2014).
  • Clinical pharmacology and bio pharmaceutics review(s) of alectinib . US Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000ClinPharmR.pdf.
  • Alectinib Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf.
  • Li W , ZhangJ, TseFLS. Handbook of LC–MS Bioanalysis: Best Practices, Experimental Protocols, and Regulations. John Wiley & Sons, NJ, USA (2013).
  • Trufelli H , PalmaP, FamigliniG, CappielloA. An overview of matrix effects in liquid chromatography–mass spectrometry. Mass Spectrom. Rev. 30, 491–509 (2010).
  • Annesley T . Ion suppression in mass spectrometry. Clin. Chem. 49, 1041–1044 (2003).
  • Chang MS , JiQ, ZhangJ, El-ShourbagyTA. Historical review of sample preparation for chromatographic bioanalysis: pros and cons. Drug Dev. Res. 68, 107–133 (2007).
  • Bylda C , ThieleR, KoboldU, VolmerD. Recent advances in sample preparation techniques to overcome difficulties encountered during quantitative analysis of small molecules from biofluids using LC–MS/MS. Analyst139, 2265–2276 (2014).
  • Ramesh B , ManjulaN, BijargiSR, SarmaVUM, Sita DeviP. Comparison of conventional and supported liquid extraction methods for the determination of sitagliptin and simvastatin in rat plasma by LC–ESI–MS/MS. J. Pharm. Biomed. Anal. 5 (3), 161–168 (2015).
  • Owen LJ , KeevilBG. Supported liquid extraction as an alternative to solid phase extraction for LC–MS/MS aldosterone analysis?Ann. Clin. Biochem. 51, 309–311 (2014).
  • Kataoka H , SaitoK. Recent advances in column switching sample preparation in bioanalysis. Bioanalysis4 (7), 809–832 (2012).
  • Bourgogne E , GrivetC, VaresioE, HopfgartnerG. Generic on-line solid phase extraction sample preparation strategies for the analysis of drugs in biological matrices by LC–MS/MS. J. Pharm. Biomed. Anal. 102, 290–298 (2015).
  • Guidance for Industry Bio analytical Method Validation. US Department of Health and Human Services, US FDA, Rockville, MD, USA (2001). www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.
  • Xu X , JiQC, JemalMet al. Fit-for-purpose bio analytical cross-validation for LC–MS/MS assays in clinical studies. Bioanalysis5 (1), 83–90 (2013).
  • Georgiou A , DongK, HughesS, BarfieldM. An inter-laboratory transfer of a multi-analyte assay between continents. Bioanalysis7 (7), 825–831 (2015).
  • Viswanathan CT , BansalS, BoothBet al. Workshop/conference report – quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9 (1), E30–E42 (2007).
  • Fast DM , KelleyM, ViswanathanCTet al. Workshop report and follow-up – AAPS workshop on current topics in GLP bio analysis: assay reproducibility for incurred samples – implications of crystal city recommendations. AAPS J. 11 (2), 239–241 (2009).
  • Kasel D , TimmermanPh. Incurred sample reanalysis: EBF’s perspective and experience. Presented at : 4th Annual Bioanalysis in Clinical Research. London, UK, 11–12 February 2009.
  • Guideline on bio analytical method validation. European Medicines Agency, London, UK (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  • Guideline on bio analytical method validation in pharmaceutical development. Ministry of Health, Labour and Welfare, Japan (2013). www.nihs.go.jp/drug/BMV/BMV_draft_130415_E.pdf.
  • King R , BonfiglioR, Fernandez-MetzlerC, Miller-SteinC, OlahT. Mechanistic investigation of ionization suppression in electrospray ionization. J. Am. Soc. Mass Spectrom. 11, 942–950 (2000).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.