Evaluation of the tissue distribution, excretion, and cytochrome P450 induction studies of a potential antitumor agent, TM-2, in animals using LC-MS/MS

References

• Bissery MC. (1995). Preclinical pharmacology of docetaxel. Eur J Cancer 31A:S1–6
   PubMed Web of Science ®Google Scholar
• CDER (Center for Drug Evaluation and Research). (2001). Guidance for industry, bioanalytical method validation, US FDA. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070107.pdf [last accessed 18 Jul 2012]
   Google Scholar
• CDER (Center for Drug Evaluation and Research). (2015). Product Development Under the Animal Rule Guidance for Industry, US FDA. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf
   Google Scholar
• Chandasana H, Chhonker YS, Laxman TS, et al. (2016). Assessment of the pharmacokinetics, tissue distribution and excretion studies of a novel antiplatelet agent S007-867, following administration to the rats. Drug Test Anal 8:723–9
   PubMed Web of Science ®Google Scholar
• China Food and Drug Administration. (2005). Guidance for preclinical pharmacokinetics of chemical drug. Available from: http://www.sda.gov.cn/gsz05106/15.pdf [last accessed 28 Apr 2012]
   Google Scholar
• Cisternino S, Bourasset F, Archimbaud Y, et al. (2003). Nonlinear accumulation in the brain of the new taxoid TXD258 following saturation of P-glycoprotein at the blood–brain barrier in mice and rats. Br J Pharmacol 138:1367–75
   PubMed Web of Science ®Google Scholar
• Crommentuyn KML, Schellens JHM, Van den Berg JD, Beijen JH. (1998). In-vitro metabolism of anti-cancer drugs, methods and applications: paclitaxel, docetaxel, tamoxifen and ifosfamide. Cancer Treat Rev 24:345–66
   PubMed Web of Science ®Google Scholar
• Ding Y, Jia Y, Lu C, et al. (2012). In vitro assessment of cytochrome P450 inhibition and induction potential offelotaxel (SHR110008). Biomed Pharmacother 66:318–21
   PubMed Web of Science ®Google Scholar
• Ding Y, Liu W, Lu C, et al. (2012). Preclinical pharmacokinetic analysis of felotaxel (SHR110008), a novel derivative of docetaxel, in rats and its protein binding ability in vitro. Biomed Chromatogr 66:98–102
   Google Scholar
• Donato MT, Castel JV. (2003). Strategies and molecular probes to investigate the role of cytochrome P450 in drug metabolism. Clin Pharmacokinet 42:153–78
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. (2011). Assessment Report for Jevtana (Cabazitaxel). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002018/WC500104766.pdf [last accessed 16 Dec 2011]
   Google Scholar
• Gut I, Ojima I, Vaclavikova R, et al. (2006). Metabolism of new-generation taxanes in human, pig, minipig and rat liver microsomes. Xenobiotica 36:772–92
   PubMed Web of Science ®Google Scholar
• Hu J, You F, Yang S, Li Y. (2014). Quantitative determination of Lx2-32c, a novel taxane derivative, in rat plasma by liquid chromatography–tandem mass spectrometry. J Pharm Biomed Anal 88:483–8
   PubMed Web of Science ®Google Scholar
• ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). (2010). S9 Nonclinical Evaluation for Anticancer Pharmaceuticals. Available from:: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm085389.pdf [last accessed 5 Apr 2012]
   Google Scholar
• ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). (2010). M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm073246.pdf [last accessed 16 Apr 2012]
   Google Scholar
• Iqbal M, Ezzeldin E, Bhat MA, et al. (2016). Preclinical pharmacokinetics, tissue distribution and excretion studies of a novel anti-candidal agent-thiosemicarbazide derivative of isoniazid (TSC-INH) by validated UPLC–MS/MS assay. J Pharm Biomed Anal 117:109–17
   PubMed Web of Science ®Google Scholar
• Li Y, Geng M, Wang J, et al. 2011. Preparation and application of Taxanes derivative against Multi-Drug Resistant Tumor. CN Patent. CN 102241648 A, Publ. date November 16, 2011
   Google Scholar
• Lin H, Zhao Y, Men L, et al. (2015). Development of a rapid and sensitive UPLC-MS/MS assay for the determination of TM-2 in beagle dog plasma and its application to a pharmacokinetic study. Biomed Chromatogr 29:110–14
   PubMed Web of Science ®Google Scholar
• Liu H, Wu P, Yang M, et al. (2016). Application of a UPLC–MS/MS method to the protein binding study of TM-2 in rat, human and beagle dog plasma. J Pharm Anal 6:32–8
   PubMed Web of Science ®Google Scholar
• Liu Z, Feng Y, Zhang L, et al. (2013). Pharmacokinetics and tissue distribution of larotaxel in rats: comparison of larotaxel-loaded microsphere with larotaxel-solution. Cancer Chemother Pharmacol 71:1131–9
   PubMed Web of Science ®Google Scholar
• Lowry OH, Rosebrough NJ, Farr AL, Randall RJ. (1951). Protein measurement with the Folin phenol reagent. J Biol Chem 193:265–75
   PubMed Web of Science ®Google Scholar
• Ly VT, Caceres-Cortes J, Zhang D, et al. (2009). Metabolism and excretion of an oral taxane analog, [14C]3′-tert-butyl-3′-N-tert-butyloxycarbonyl-4-deacetyl-3′-dephenyl-3′-N-debenzoyl-4-O-methoxy-paclitaxel (BMS-275183), in rats and dogs. Drug Metab Dispos 37:1115–28
   PubMed Web of Science ®Google Scholar
• Marangon E, Falcioni C, Manzotti C, et al. (2009). Development and validation of a LC-MS/MS method for the determination of the novel oral 1, 14 substituted taxane derivatives, IDN 5738 and IDN 5839, in mouse plasma and its application to the pharmacokinetic study. J Chromatogr B 877:4147–53
   PubMed Web of Science ®Google Scholar
• Men L, Lin H, Zhao Y, et al. (2014a). Metabolism of TM-2, a potential antitumor drug, in rats by using LC-MS. J Sep Sci 37:625–9
   PubMed Web of Science ®Google Scholar
• Men L, Zhao Y, Lin H, et al. (2014b). Characterization of in vitro metabolites of TM-2, a potential antitumor drug, in rat, dog and human liver microsomes using liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom 28:2162–70
   PubMed Web of Science ®Google Scholar
• Men L, Zhao Y, Lin H, et al. (2015). Application of an LC-MS/MS method to the pharmacokinetics of TM-2, a potential antitumour agent, in rats. Drug Test Anal 7:544–9
   PubMed Web of Science ®Google Scholar
• Metzger-Filho O, Moulin C, de Azambuja E, Ahmad A. (2009). Larotaxel: broadening the road with new taxanes. Expert Opin Investig Drugs 18:1183–9
   PubMed Web of Science ®Google Scholar
• Nedelcheva V, Gut I, Soucek P, Frantik E. (1998). Cytochrome P450 catalyzed oxidation of monochlorobenzene, 1,2- and 1,4-dichlorobenzene in rat, mouse, and human liver microsomes. Chem Biol Interact 115:53–70
   PubMed Web of Science ®Google Scholar
• Ojima I, Das M. (2009). Recent advances in the chemistry and biology of new generation taxoids. J Nat Prod 72:554–65
   PubMed Web of Science ®Google Scholar
• Omura T, Sato R. (1964). The carbon monoxide-binding pigment of liver microsomes: evidence for its haemoprotein nature. J Biol Chem 239:2370–8
   PubMed Web of Science ®Google Scholar
• Shi J, Chen X, Gu Y, et al. (2014). Preformulation and development of chemically stable lipid emulsions containing a novel taxane derivative, TM-2. Eur J Lipid Sci Technol 116:486–96
   Web of Science ®Google Scholar
• Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. (1996). Tissue distribution, metabolism and excretion of paclitaxel in mice. Anticancer Drugs 7:78–86
   PubMed Web of Science ®Google Scholar
• Vrignaud P, Sémiond D, Lejeune P, et al. (2013). Preclinical antitumor activity of cabazitaxel, a semisynthetic taxane active in taxane-resistant tumors. Clin Cancer Res 19:2973–83
   PubMed Web of Science ®Google Scholar
• Yared JA, Tkaczuk KH. (2012). Update on taxane development: new analogs and new formulations. Drug Des Dev Ther 6:371–84
   PubMed Web of Science ®Google Scholar
• Zhang J, Ge G, Liu Y, et al. (2008). Taxane's substituents at C3′ affect its regioselective metabolism: different in vitro metabolism of cephalomannine and paclitaxel. Drug Metab Dispos 36:418–26
   PubMed Web of Science ®Google Scholar
• Zhao M, Su M, Lin X, et al. (2010). Evaluation of docetaxel-loaded intravenous lipid emulsion: pharmacokinetics, tissue distribution, antitumor activity, safety and toxicity. Pharm Res 27:1687–702
   PubMed Web of Science ®Google Scholar