Chapter 17
Standard-Free Estimation of Metabolite Levels Using Nanospray Mass Spectrometry: Current Statutes and Future Directions
Jing-Tao Wu,
Jing-Tao Wu
Drug Metabolism and Pharmacokinetics, Millennium Pharmaceuticals, Inc., Cambridge, MA, USA
Search for more papers by this authorJing-Tao Wu,
Jing-Tao Wu
Drug Metabolism and Pharmacokinetics, Millennium Pharmaceuticals, Inc., Cambridge, MA, USA
Search for more papers by this authorBook Editor(s):Mike S. Lee, Mingshe Zhu,
Mingshe Zhu
Department of Biotransformation, Bristol-Myers Squibb Research and Development, Princeton, New Jersey, USA
Search for more papers by this authorFirst published: 14 March 2011
Series Editor(s): Mike S. Lee,
Summary
This chapter contains sections titled:
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Introduction
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Current Approaches for Metabolite Quantitation in the Absence of Synthetic Standards
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Use of Nanospray for Standard-Free Metabolite Quantitation
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Future Directions
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References
REFERENCES
- Baillie TA, Cayen MN, Fouda H, Gerson RJ, Green JD, Grossman SJ, Klunk LJ, LeBlanc B, Perkins DG, Shipley LA. Drug metabolites in safety testing. Toxicol Appl Pharmacol 2002; 182: 188–196.
- Cole RB, Ed. Electrospray Ionization Mass Spectrometry, Fundamentals, Instrumentation and Applications. Wiley, New York, 1997.
- Deng Y, Wu J-T, Zhang H, Olah TV. Quantitation of drug metabolites in the absence of pure metabolite standards by high-performance liquid chromatography coupled to a chemiluminescence nitrogen detector and mass spectrometer. Rapid Commun Mass Spectrom 2004; 18: 1681–1685.
- Dethy J-M, Ackermann BL, Delatour C, Henion JD, Schultz GA. Demonstration of direct bioanalysis of drugs in plasma using nanoelectrospray infusion from a silicon chip coupled with tandem mass spectrometry. Anal Chem 2003; 75: 805–811.
- Espina R, Yu L, Wang J, Tong Z, Vashishtha S, Talaat R, Scatina J, Mutlib A. Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentration of biologically produced metabolites: Implications in metabolites in safety testing. Chem Res Toxicol 2009; 22: 299–310.
- Hah SS. Recent advances in biomedical applications of accelerator mass spectrometry. J Biomed Sci 2009; 16:54, pp. 111–124.
- Hop CECA, Chen Y, Yu LJ. Uniformity of ionization response of structurally diverse analyte using a chip-based nanoelectrospray ionization source. Rapid Commun Mass Spectrom 2005; 19: 3139–3142.
- Josephs JL, Luk CE, Grubb M, Yang Y, Zhang H, Cai H, Langish R, Shipkova P, Sanders M, Humphreys WG. An integrated approach to in vitro and in vivo metabolite quantitation based on high resolution full scan MS Data. Oral presentation. Presented at the 57th Annual Conference of Am Soc Mass Spectrom, Philadelphia, June 2009.
- Leclercq L, Cuyckens F, Mannens GSJ, de Vries R, Timmerman P, Evans DC. Which human metabolites have we mist? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem Res Toxicol 2009; 22: 280–293.
- Mackenzie IS. Theoretical aspects of quantitative NMR. Anal Proc 1984; 21: 500–502.
- Malz F, Jancke H. Validation of quantitative NMR. J Pharm Biomed Anal 2005; 38: 813–823.
- Ramanathan R, Zhong R, Blumenkrantz N, Chowdhury SK, Alton KB. Response normalized liquid chromatography nanospray ionization mass spectrometry. J Am Soc Mass Spectrom 2007; 18: 1891–1899.
- Schmidt A, Karas M, Dulcks T. Effect of different solution flow rates on analyte ion signals in nano-ESI MS, or: when does ESI turn into nano-ESI? J Am Soc Mass Spectrom 2003; 14: 492–500.
- Smith DA, Obach RS. Metabolites and safety: What are the concerns, and how should we address them? Chem Res Toxicol 2006; 19: 1570–1579.
- U. S. Food and Drug Administration (FDA). Guidance for Industry: Safety Testing of Drug Metabolites. FDA Center for Drug Evaluation of Research (CDER), Rockville, MD, 2008.
- Valaskovic GA, Utley L, Lee MS, Wu J-T. Ultra-low flow nanospray for the normalization of conventional liquid chromatography/mass spectrometry through equimolar response: Standard-free quantitative estimation of metabolite levels in drug discovery. Rapid Commun Mass Spectrom 2006; 20: 1087–1096.
- Van Pelt CK, Zhang S, Fung E, Chu I, Liu T, Li C, Korfmacher WA, Henion J. A fully automated nanospray tandem mass spectrometric method for analysis of Caco-2 samples. Rapid Commun Mass Spectrom 2003; 17: 1573–1578.
- Wilm MS, Mann M. Electrospray and Taylor-cone theory, Dole's beam of macromolecules at last? Int J Mass Spectrom Ion Process 1994; 136: 167–180.
- Wilm MS, Mann M. Analytical properties of the nanoelectrospray ion source. Anal Chem 1996; 68: 1–8.
- Young G, Ellis W, Ayrton J, Hussey E, Adamkiewicz B. Accelerator mass spectrometry (AMS): Recent experience of its use in a clinical study and the potential future of the technique. Xenobiotica 2001; 31: 619–632.
- Yu C, Chen CL, Gorycki FL, Neiss TGA. A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection. Rapid Commun Mass Spectrom 2007; 21: 497–502.
- Zhu M, Zhang D, Zhang H, Shyu WC. Integrated strategies for assessment of metabolite exposure in humans during drug development: Analytical challenges and clinical development considerations. Biopharm Drug Dispos 2009; 30: 163–184.