Analytical strategies for assessment of human metabolites in preclinical safety testing

Analytical Chemistry

Volumn 83, Issue 13, 2011, Pages 5028-5036

  Ma, Shuguang ^a   Chowdhury, Swapan K ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL STRATEGY; DATA-MINING TOOLS; DRUG METABOLITES; HUMAN METABOLITES; IN-VIVO;

BIOMOLECULES; METABOLISM; METABOLITES;

SAFETY TESTING;

ARTICLE; BIOTRANSFORMATION; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; TOXICITY TESTING;

BIOTRANSFORMATION; CHROMATOGRAPHY, LIQUID; HUMANS; MASS SPECTROMETRY; TOXICITY TESTS;

EID: 79960013720     PISSN: 00032700     EISSN: None     Source Type: Journal    
DOI: 10.1021/ac200349g     Document Type: Article

References (39)

1. U.S. Food and Drug Administration. Guidance for Industry: Safety Testing of Drug Metabolites. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079266.pdf. 2008.
2. International Conference on Harmonisation. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2). http://private.ich.org/LOB/media/MEDIA5544.pdf. 2009.
3. Ma, S.; Chowdhury, S. K.; Alton, K. B. Curr. Drug Metab. 2006, 7, 503-523
4. Zhang, H.; Zhang, D.; Ray, K. J. Mass Spectrom. 2003, 38, 1110-1112
5. Zhang, H.; Zhang, D.; Ray, K.; Zhu, M. J. Mass Spectrom. 2009, 44, 999-1016
6. Zhang, H.; Ma, L.; He, K.; Zhu, M. J. Mass Spectrom. 2008, 43, 1191-1200
7. Zhang, H.; Yang, Y. J. Mass Spectrom. 2008, 43, 1181-1190
8. Zhu, P.; Ding, W.; Tong, W.; Ghosal, A.; Alton, K.; Chowdhury, S. Rapid Commun. Mass Spectrom. 2009, 23, 1563-1572
9. Zhu, P.; Tong, W.; Alton, K.; Chowdhury, S. Anal. Chem. 2009, 81, 5910-5917
10. Zhang, H.; Zhu, M.; Ray, K. L.; Ma, L.; Zhang, D. Rapid Commun. Mass Spectrom. 2008, 22, 2082-2088
11. Ma, S.; Chowdhury, S. K. In Drug Metabolism in Drug Design and Development; Zhang, D.; Zhu, M.; Humphreys, W. G., Eds.; John Wiley & Sons, Inc.: Hoboken, NJ, 2008, pp 319-367.
12. Anari, M. R.; Sanchez, R. I.; Bakhtiar, R.; Franklin, R. B.; Baillie, T. A. Anal. Chem. 2004, 76, 823-832
13. Mortishire-Smith, R. J.; Castro-Perez, J. M.; Yu, K.; Shockcor, J. P.; Goshawk, J.; Hartshorn, M., J.; Hill, A. Rapid Commun. Mass Spectrom. 2009, 23, 939-948
14. Zhu, M.; Ma, L.; Zhang, D.; Ray, K.; Zhao, W.; Humphreys, W. G.; Skiles, G.; Sanders, M.; Zhang, H. Drug Metab. Dispos. 2006, 34, 1722-1733
15. Bateman, K. P.; Castro-Perez, J.; Wrona, M.; Shockcor, J. P.; Yu, K.; Oballa, R.; Nicoll-Griffith, D. A. Rapid Commun. Mass Spectrom. 2007, 21, 1485-1496
16. Bonn, B.; Leandersson, C.; Fontaine, F.; Zamora, I. Rapid Commun. Mass Spectrom. 2010, 24, 3127-3138
17. Yang, Z. J. Pharm. Biomed. Anal. 2006, 40, 516-527
18. Penner, N. A.; Ho, G.; Bercovici, A.; Chowdhury, S. K.; Alton, K. B. Drug Metab. Dispos. 2010, 38, 2067-2074
19. Liu, D. Q.; Wu, L.; Sun, M.; MacGregor, P. A. J. Pharm. Biomed. Anal. 2007, 44, 320-329
20. Liu, D. Q.; Hop, C. E. J. Pharm. Biomed. Anal. 2005, 37, 1-18
21. Wright, P.; Miao, Z.; Shilliday, B. Bioanalysis 2009, 1, 831-845
22. Yu, C.; Chen, C. L.; Gorycki, F. L.; Neiss, T. G. Rapid Commun. Mass Spectrom. 2007, 21, 497-502
23. Ramanathan, R.; Zhong, R.; Blumenkrantz, N.; Chowdhury, S. K.; Alton, K. B. J. Am. Soc. Mass Spectrom. 2007, 18, 1891-1899
24. Valaskovic, G. A.; Utley, L.; Lee, M. S.; Wu, J. T. Rapid Commun. Mass Spectrom. 2006, 20, 1087-1096
25. Hop, C. E.; Chen, Y.; Yu, L. J. Rapid Commun. Mass Spectrom. 2005, 19, 3139-3142
26. Brown, K.; Dingley, K. H.; Turteltaub, K. W. Methods Enzymol. 2005, 402, 423-443
27. Lappin, G.; Garner, R. C. Anal. Bioanal. Chem. 2004, 378, 356-364
28. Lappin, G.; Garner, R. C. Expert. Opin. Drug Metab. Toxicol. 2005, 1, 23-31
29. Prakash, C.; Shaffer, C. L.; Tremaine, L. M.; Liberman, R. G.; Skipper, P. L.; Flarakos, J.; Tannenbaum, S. R. Drug Metab. Lett. 2007, 1, 226-231
30. Liberman, R. G.; Tannenbaum, S. R.; Hughey, B. J.; Shefer, R. E.; Klinkowstein, R. E.; Prakash, C.; Harriman, S. P.; Skipper, P. L. Anal. Chem. 2004, 76, 328-334
31. Murnick, D. E.; Dogru, O.; Ilkmen, E. Anal. Chem. 2008, 80, 4820-4824
32. Espina, R.; Yu, L.; Wang, J.; Tong, Z.; Vashishtha, S.; Talaat, R.; Scatina, J.; Mutlib, A. Chem. Res. Toxicol. 2009, 22, 299-310
33. Vishwanathan, K.; Babalola, K.; Wang, J.; Espina, R.; Yu, L.; Adedoyin, A.; Talaat, R.; Mutlib, A.; Scatina, J. Chem. Res. Toxicol. 2009, 22, 311-322
34. Martino, R.; Gilard, V.; Desmoulin, F.; Malet-Martino, M. J. Pharm. Biomed. Anal. 2005, 38, 871-891
35. Lenz, E. M.; Wilson, I. D.; Wright, B.; Partridge, E. A.; Rodgers, C. T.; Haycock, P. R.; Lindon, J. C.; Nicholson, J. K. J. Pharm. Biomed. Anal. 2002, 28, 31-43
36. Hamilton, R. A.; Garnett, W. R.; Kline, B. J. Clin. Pharmacol. Ther. 1981, 29, 408-413
37. Hop, C. E.; Wang, Z.; Chen, Q.; Kwei, G. J. Pharm. Sci. 1998, 87, 901-903
38. Gao, H.; Deng, S.; Obach, R. S. Drug Metab. Dispos. 2010, 38, 2147-2156
39. Ma, S.; Li, Z.; Lee, K. J.; Chowdhury, S. K. Chem. Res. Toxicol. 2010, 23, 1871-1873