Bio-generation of stable isotope labeled internal standards for absolute and relative quantitation of drug metabolites in plasma samples by LC-MS/MS

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 926, Issue , 2013, Pages 92-100

  Li, Pei ^a   Gong, Yong ^b   Lim, Heng Keang ^b   Jian, Wenying ^b   Edom, Richard W ^b   Salter, Rhys ^b   Silva, Jose ^b   Weng, Naidong ^b  

^a UNIVERSITY OF GEORGIA   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

Author keywords

LC MS MS analysis; Metabolite; Microsomal incubation; MIST; Quantitation; Relative exposure coverage; Stable isotope labeled internal standard

Indexed keywords

LC-MS/MS; MICROSOMAL INCUBATION; QUANTITATION; RELATIVE EXPOSURE COVERAGE; STABLE ISOTOPE LABELED INTERNAL STANDARDS;

FOG; ISOTOPES; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METABOLITES; SAFETY TESTING;

BIOMOLECULES;

DRUG METABOLITE; ISOTOPE;

ACCURACY; ARTICLE; CONCENTRATION (PARAMETERS); DRUG METABOLISM; IN VITRO STUDY; INCUBATION TIME; IONIZATION; ISOTOPE LABELING; LIPOPHILICITY; LIQUID CHROMATOGRAPHY; MICROSOME; PRIORITY JOURNAL; STANDARD; TANDEM MASS SPECTROMETRY;

CHROMATOGRAPHY, LIQUID; HUMANS; ISOTOPES; LIMIT OF DETECTION; MICROSOMES; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY;

EID: 84876031277     PISSN: 15700232     EISSN: 1873376X     Source Type: Journal    
DOI: 10.1016/j.jchromb.2013.03.006     Document Type: Article

References (23)

1. Baillie T.A., Cayen M.N., Fouda H., Gerson R.J., Green J.D., Grossman S.J., Klunk L.J., LeBlanc B., Perkins D.G., Shipley L.A. Toxicol. Appl. Pharmacol. 2002, 182:188.
2. Leclercq L., Cuyckens F., Mannens G.S.J., de Vries R., Timmerman P., Evans D.C. Chem. Res. Toxicol. 2009, 22:280.
3. Liebler D.C., Guengerich F.P. Nat. Rev. Drug Discov. 2005, 4:410.
4. FDA, Guidance for industry: safety testing of drug metabolites (2008).
5. ICH, Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3 (R2) (2009).
6. Atrakchi A.H. Chem. Res. Toxicol. 2009, 22:1217.
7. Frederick C.B., Obach R.S. Clin. Pharmacol. Ther. 2010, 87:345.
8. Gao H., Obach R.S. Curr. Drug Metab. 2011, 12:578.
9. Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. Pharm. Res. 2007, 24:1962.
10. Timmerman P., Anders Kall M., Gordon B., Laakso S., Freisleben A., Hucker R. Bioanalysis 2010, 2:1185.
11. Vishwanathan K., Babalola K., Wang J., Espina R., Yu L., Adedoyin A., Talaat R., Mutlib A., Scatina J. Chem. Res. Toxicol. 2009, 22:311.
12. Yang Y., Grubb M.F., Luk C.E., Humphreys W.G., Josephs J.L. Rapid Commun. Mass Spectrom. 2011, 25:3245.
13. Yu C., Chen C.L., Gorycki F.L., Neiss T.G. Rapid Commun. Mass Spectrom. 2007, 21:497.
14. Vrbanac J.J., Hilgers A., Dubnicka T., Shilliday F.B., Humphries D., Hayes R.N. Rapid Commun. Mass Spectrom. 2012, 26:2569.
15. Espina R., Yu L., Wang J., Tong Z., Vashishtha S., Talaat R., Scatina J., Mutlib A. Chem. Res. Toxicol. 2008, 22:299.
16. Gao H., Deng S., Obach R.S. Drug Metab. Dispos. 2010, 38:2147.
17. Gao H., Obach R.S. Drug Metab. Dispos. 2012, 40:1290.
18. Ma S., Li Z., Lee K.J., Chowdhury S.K. Chem. Res. Toxicol. 2010, 23:1871.
19. Jian W., Edom R.W., Xu Y., Gallagher J., Weng N. J. Chromatogr. B 2010, 878:3267.
20. S.M. Bjorge, Pharmacochemistry Library, 1997, p. 233.
21. Turfus S.C., Parkin M.C., Cowan D.A., Halket J.M., Smith N.W., Braithwaite R.A., Elliot S.P., Steventon G.B., Kicman A.T. Drug Metab. Dispos. 2009, 37:1769.
22. Wind M., Gebhardt K., Grunwald H., Spickermann J., Donzelli M., Kellenberger L., Muller M., Fullhardt P., Schmitt-Hoffmann A., Schleimer M. Rapid Commun. Mass Spectrom. 2007, 21:1093.
23. Shao L., Hewitt M.C. Drug News Perspect. 2010, 23:398.