Development and validation of a bioanalytical method for the quantification of the CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse matrices using liquid chromatography-tandem mass spectrometry
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Santhosh S, Kumar P, Ramprasad V, Chaudhuri A. Evolution of targeted therapies in cancer: opportunities and challenges in the clinic. Future Oncol. 2015;11:279–93. https://doi.org/10.2217/fon.14.198 .
Malínková V, Vylíčil J, Kryštof V. Cyclin-dependent kinase inhibitors for cancer therapy: a patent review (2009 – 2014). Expert Opin Ther Pat. 2015;25:953–70. https://doi.org/10.1517/13543776.2015.1045414 .
O’Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol. 2016;13:417–30. https://doi.org/10.1038/nrclinonc.2016.26 .
Chen P, Lee NV, Hu W, Xu M, Ferre RA, Lam H, et al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol Cancer Ther. 2016;15:2273–81. https://doi.org/10.1158/1535-7163.MCT-16-0300 .
Kwapisz D. Cyclin-dependent kinase 4/6 inhibitors in breast cancer: palbociclib, ribociclib, and abemaciclib. Breast Cancer Res Treat. 2017;166:41–54. https://doi.org/10.1007/s10549-017-4385-3 .
Klein ME, Kovatcheva M, Davis LE, Tap WD, Koff A. CDK4/6 inhibitors: the mechanism of action may not be as simple as once thought. Cancer Cell. 2018;34:1–12. https://doi.org/10.1016/j.ccell.2018.03.023 .
Vidula N, Rugo HS. Cyclin-dependent kinase 4/6 inhibitors for the treatment of breast cancer: a review of preclinical and clinical data. Clin Breast Cancer. 2016;16:8–17. https://doi.org/10.1016/j.clbc.2015.07.005 .
Nguyen L, Zhong WZ, Painter CL, Zhang C, Rahavendran SV, Shen Z. Quantitative analysis of PD 0332991 in xenograft mouse tumor tissue by a 96-well supported liquid extraction format and liquid chromatography/mass spectrometry. J Pharm Biomed Anal. 2010;53:228–34. https://doi.org/10.1016/j.jpba.2010.02.031 .
Smith D, Tella M, Rahavendran SV, Shen Z. Quantitative analysis of PD 0332991 in mouse plasma using automated micro-sample processing and microbore liquid chromatography coupled with tandem mass spectrometry. J Chromatogr B. 2011;879:2860–5. https://doi.org/10.1016/j.jchromb.2011.08.009 .
Paul D, Surendran S, Chandrakala P, Satheeshkumar N. An assessment of the impact of green tea extract on palbociclib pharmacokinetics using a validated UHPLC–QTOF–MS method. Biomed Chromatogr. 2019;33:1–9. https://doi.org/10.1002/bmc.4469 .
Paul D, Chandrakala P, Surendran S, Bitla P, Satheeshkumar N. Pharmacokinetic interaction study of novel combination of palbociclib and sorafenib for hepatocellular carcinoma in SD rats. J Chromatogr B. 2019;1108:25–31. https://doi.org/10.1016/j.jchromb.2019.01.003 .
Kala A, Patel YT, Davis A, Stewart CF. Development and validation of LC–MS/MS methods for the measurement of ribociclib, a CDK4/6 inhibitor, in mouse plasma and Ringer’s solution and its application to a cerebral microdialysis study. J Chromatogr B. 2017;1057:110–7. https://doi.org/10.1016/j.jchromb.2017.05.002 .
Bao X, Wu J, Sanai N, Li J. Determination of total and unbound ribociclib in human plasma and brain tumor tissues using liquid chromatography coupled with tandem mass spectrometry. J Pharm Biomed Anal. 2019;166:197–204. https://doi.org/10.1016/j.jpba.2019.01.017 .
Raub TJ, Wishart GN, Kulanthaivel P, Staton BA, Ajamie RT, Sawada GA, et al. Brain exposure of two selective dual CDK4 and CDK6 inhibitors and the antitumor activity of CDK4 and CDK6 inhibition in combination with temozolomide in an intracranial glioblastoma xenograft. Drug Metab Dispos. 2015;43:1360–71. https://doi.org/10.1124/dmd.114.062745 .
FDA. Guidance for Industry Bioanalytical Method Validation. 2018;1–22. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Accessed 05 Jun 2018.
European Medicines Agency. Guideline on bioanalytical method validation. 2012;44:1–23. https://www.ema.europa.eu/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf . Accessed 05 Jun 2018.