Development and full validation of six inhibition assays for five major cytochrome P450 enzymes in human liver microsomes using an automated 96-well microplate incubation format and LC-MS/MS analysis

Journal of Pharmaceutical and Biomedical Analysis

Volumn 44, Issue 1, 2007, Pages 211-223

  Yao, Ming ^a   Zhu, Mingshe ^a   Sinz, Michael W ^a   Zhang, Hongjian ^a   Humphreys, W Griffith ^a   Rodrigues, A David ^a   Dai, Renke ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Assay validation; Automation; CYP inhibition; Filtration; Human liver microsomes; LC MS MS analysis

Indexed keywords

1' HYDROXYTIRAZOLAM; 4 HYDROXYBUTYRANILIDE; 4 HYDROXYPHENACETIN; 4' HYDROXYDICLOFENAC; 4' HYDROXYMEPHENYTOIN; 6 HYDROXYPROGESTERONE; 6BETA HYDROXYTESTOSTERONE; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOCHROME P450 INHIBITOR; DEXTROMETHORPHAN; DEXTRORPHAN; DICLOFENAC; DRUG METABOLITE; FLUFENAMIC ACID; MEPHENYTOIN; MIDAZOLAM; PHENACETIN; PHENYTOIN; PROPRANOLOL DERIVATIVE; TESTOSTERONE; UNCLASSIFIED DRUG;

ACCURACY; ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG INHIBITION; DRUG STABILITY; DRUG STRUCTURE; ELUTION; ENZYME KINETICS; FILTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; IC 50; INCUBATION TIME; LIVER MICROSOME; MASS SPECTROMETRY; MEDICAL LITERATURE; MOLECULAR PROBE; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; SUSTAINED RELEASE PREPARATION;

ARYL HYDROCARBON HYDROXYLASES; AUTOANALYSIS; BIOLOGICAL ASSAY; CHROMATOGRAPHY, LIQUID; CYTOCHROME P-450 CYP1A2; CYTOCHROME P-450 CYP2D6; CYTOCHROME P-450 ENZYME SYSTEM; ENZYME INHIBITORS; HUMANS; INHIBITORY CONCENTRATION 50; ISOENZYMES; KINETICS; MICROSOMES, LIVER; MIXED FUNCTION OXYGENASES; MOLECULAR STRUCTURE; REPRODUCIBILITY OF RESULTS; SUBSTRATE SPECIFICITY; TANDEM MASS SPECTROMETRY;

EID: 34047252007     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.02.034     Document Type: Article

References (40)

1. Nelson D.R., Koymans L., Kamataki T., Stegeman J.J., Feyereisen R., Waxman D.J., Waterman M.R., Gotoh O., Coon M.J., Estabrook R.W., Gunsalus I.C., and Nebert D.W. Pharmacogenetics 6 (1996) 1-42
2. Lazarou J., Pomeranz B.H., and Corey P.N. JAMA 279 (1998) 1200-1205
3. Alfaro C.L. Psychopharmacol. Bull. 35 (2001) 80-93
4. Krayenbuhl J.C., Vozeh S., Kondo-Oestreicher M., and Dayer P. Eur. J. Clin. Pharmacol. 55 (1999) 559-565
5. Vazquez E., and Whitfield L. Posit. Aware. 8 (1997) 12
6. FDA, Guidance for Industry: Drug Metabolism/Drug Interaction Studies In Drug Development Process, Studies In Vitro, April 1997.
7. FDA, Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies, Study Design, Data Analysis, and Recommendations for Dosing and Labeling, November 1999.
8. Donato M.T., Jimenez N., Castell J.V., and Gomez-Lechon M.J. Drug Metab. Dispos. 32 (2004) 699-706
9. Stresser D.M., Turner S.D., Blanchard A.P., Miller V.P., and Crespi C.L. Drug Metab. Dispos. 30 (2002) 845-852
10. Peng S.X., Barbone A.G., and Ritchie D.M. Rapid Commun. Mass Spectrom. 17 (2003) 509-518
11. Yuan R., Madani S., Wei X.X., Reynolds K., and Huang S.M. Drug Metab. Dispos. 30 (2002) 1311-1319
12. Chu I., Favreau L., Soares T., Lin C., and Nomeir A.A. Rapid Commun. Mass Spectrom. 14 (2000) 207-214
13. Ayrton J., Plumb R., Leavens W.J., Mallett D., Dickins M., and Dear G.J. Rapid Commun. Mass Spectrom. 12 (1998) 217-224
14. Shou M., Lin Y., Lu P., Tang C., Mei Q., Cui D., Tang W., Ngui J.S., Lin C.C., Singh R., Wong B.K., Yergey J.A., Lin J.H., Pearson P.G., Baillie T.A., Rodrigues A.D., and Rushmore T.H. Curr. Drug Metab. 2 (2001) 17-36
15. Cohen L.H., Remley M.J., Raunig D., and Vaz A.D. Drug Metab. Dispos. 31 (2003) 1005-1015
16. Nomeir A.A., Ruegg C., Shoemaker M., Favreau L.V., Palamanda J.R., Silber P., and Lin C.C. Drug Metab. Dispos. 29 (2001) 748-753
17. Wang R.W., Newton D.J., Liu N., Atkins W.M., and Lu A.Y. Drug Metab. Dispos. 28 (2000) 360-366
18. Kenworthy K.E., Bloomer J.C., Clarke S.E., and Houston J.B. Br. J. Clin. Pharmacol. 48 (1999) 716-727
19. Wienkers L.C. J. Pharmacol. Toxicol. Methods 45 (2001) 79-84
20. Dierks E.A., Stams K.R., Lim H.K., Cornelius G., Zhang H., and Ball S.E. Drug Metab. Dispos. 29 (2001) 23-29
21. Bu H.Z., Magis L., Knuth K., and Teitelbaum P. Rapid Commun. Mass Spectrom. 15 (2001) 741-748
22. Zhang T., Zhu Y., and Gunaratna C. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 780 (2002) 371-379
23. Testino Jr. S.A., and Patonay G. J. Pharm. Biomed. Anal. 30 (2003) 1459-1467
24. Yin H., Racha J., Li S.Y., Olejnik N., Satoh H., and Moore D. Xenobiotica 30 (2000) 141-154
25. Turpeinen M., Korhonen L.E., Tolonen A., Uusitalo J., Juvonen R., Raunio H., and Pelkonen O. Eur. J. Pharm. Sci. 29 (2006) 130-138
26. Bajpai M., and Esmay J.D. Drug Metab. Rev. 34 (2002) 679-689
27. Kremers P. Pharmacol. Toxicol. 91 (2002) 209-217
28. Bjornsson T.D., Callaghan J.T., Einolf H.J., Fischer V., Gan L., Grimm S., Kao J., King S.P., Miwa G., Ni L., Kumar G., McLeod J., Obach R.S., Roberts S., Roe A., Shah A., Snikeris F., Sullivan J.T., Tweedie D., Vega J.M., Walsh J., and Wrighton S.A. Drug Metab. Dispos. 31 (2003) 815-832
29. Walsky R.L., and Obach R.S. Drug Metab. Dispos. 32 (2004) 647-660
30. Lim H.K., Duczak Jr. N., Brougham L., Elliot M., Patel K., and Chan K. Drug Metab. Dispos. 33 (2005) 1211-1219
31. FDA, Guidance for Industry: Bioanalytical Method Validation, May 2001.
32. Obach R.S. Drug Metab. Dispos. 25 (1997) 1359-1369
33. University of Washington, Metabolism & Transport Drug Interaction Database http://www.druginteractioninfo.org/, 2005.
34. Atkinson A., Kenny J.R., and Grime K. Drug Metab. Dispos. 33 (2005) 1637-1647
35. Biddlecombe R.A., and Pleasance S. J. Chromatogr. B Biomed. Sci. Appl. 734 (1999) 257-265
36. Rouan M.C., Buffet C., Marfil F., Humbert H., and Maurer G. J. Pharm. Biomed. Anal. 25 (2001) 995-1000
37. Berna M., Murphy A.T., Wilken B., and Ackermann B. Anal. Chem. 74 (2002) 1197-1201
38. Moody G.C., Griffin S.J., Mather A.N., McGinnity D.F., and Riley R.J. Xenobiotica 29 (1999) 53-75
39. Rendic S., and Di Carlo F.J. Drug Metab. Rev. 29 (1997) 413-580
40. Whalley P.M., Bakes D., Grime K., and Weaver R.J. J. Chromatogr. B Biomed. Sci. Appl. 760 (2001) 281-288