The conduct of drug metabolism studies considered good practice (I): Analytical systems and in vivo studies

Current Drug Metabolism

Volumn 8, Issue 8, 2007, Pages 815-821

  Liu, Xiaodong ^a   Jia, Lee ^b,c  

^a CHINA PHARMACEUTICAL UNIVERSITY   (China)

^b NATIONAL CANCER INSTITUTE   (United States)

^c NONE   (United States)

Author keywords

Analytical techniques; Drug regulations; In vivo drug metabolism; Interspecies differences; Major drug metabolites; Metabolite identification; Pharmacokinetics; Radiolabeled drug

Indexed keywords

ACYLTRANSFERASE; ALCOHOL DEHYDROGENASE; BETA GLUCURONIDASE; CYTOCHROME P450 3A; DRUG METABOLITE; EPOXIDE HYDROLASE; ESTERASE; GLUCOSYLTRANSFERASE; GLUTATHIONE TRANSFERASE; GLYCOPROTEIN P; GLYCOSIDASE; GOSSYPOL; MIDAZOLAM; MULTIDRUG RESISTANCE PROTEIN; SALAZOSULFAPYRIDINE; SULFATASE; SULFOTRANSFERASE;

AREA UNDER THE CURVE; BACTERIAL METABOLISM; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTROL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG EXPOSURE; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; ENZYME ACTIVITY; FIRST PASS EFFECT; GAS CHROMATOGRAPHY; HUMAN; IN VITRO STUDY; IN VIVO STUDY; ISOTOPE LABELING; LIQUID CHROMATOGRAPHY; LIVER METABOLISM; MASS SPECTROMETRY; MICROFLUIDICS; NONHUMAN; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; QUANTITATIVE ANALYSIS; RADIOIMMUNOASSAY; RELIABILITY; REVIEW; SENSITIVITY AND SPECIFICITY; SPECIES DIFFERENCE; TANDEM MASS SPECTROMETRY;

ADULT; ANIMALS; CHILD; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 36949031034     PISSN: 13892002     EISSN: None     Source Type: Journal    
DOI: 10.2174/138920007782798153     Document Type: Review

References (54)

1. U.S. FDA Guidance for Industry (1997). Drug metabolism/drug interaction studies in the drug development process: studies in vitro. www.fda.gov/cder/guidance.
2. Kostiainen, R.; Kotiaho, T.; Kuuranne, T. and Auriola, S. (2003) J. Mass Spectrom., 38, 357-372.
3. Beumer, J. H.; Beijne, J.H. and Schellens, J.H.M. (2006) Clin. Pharmacokinet., 45, 33-58.
4. Barker, J. and Garner, R.C. (1999) Rapid Commun. Mass Spectrom., 13, 285-290.
5. Jia, L.; Wong, H.; Wang, Y.; Garza, M. and Weitman, S.D. (2003) J. Pharm. Sci., 92, 161-172.
6. Jia, L.; Noker, P.E.; Coward, L.; Gorman, G.; Protopopova, M. and Tomaszewski, J.E. (2006) Br. J. Pharmacol., 147, 476-485.
7. Kairemo, K.J.A. and Tahtinen, M. (2004) Curr. Pharm. Des., 10, 2923-2934.
8. Garner, R.C. and Lappin, G. (2006) Br. J. Clin. Pharmacol., 61, 367-370.
9. Lappin, G. and Garner, R.C. (2003) Nat. Rev. Drug Discov., 2, 233-240.
10. Jia, L.; Yu, L.; Linnik, D.M. and Jack, R.M. (2001) J. Pharm. Pharmacol., 53, 999-1005.
11. Liu, X.D.; Xie, L.; Gao, J.P.; Lai, L.S. and Liu, G.Q. (1997) Eur. J. Drug Metab. Pharmacokinet., 22, 185-188.
12. Deng, Y.X.; Lu, T.; Xie, L. and Liu, X.D. (2005) Biomed. Chromatogr., 20, 1098-1002.
13. Chen, W.D.; Liang, Y.; Xie, L.; Lu, T.; Liu, X.D. and Wang, G.J. (2007) Biol. Pharm. Bull., 30, 1-5.
14. Chen, W.D.; Liang, Y.; Li, H.; Xiong, Y.; Liu, X.D.; Wang, G.J. and Xie, L. (2006) J. Pharm. Biomed. Anal., 41, 256-260.
15. Lu, T.; Liang, Y.; Song, J.; Xie, L.; Wang, G.J. and Liu, X.D. (2006) J. Pharm. Biomed. Anal., 40, 1218-24.
16. Jia, L.; Tomaszewski, J.E.; Noker, P.E.; Gorman, G.S.; Glaze, E. and Protopopova, M. (2005) J. Pharm. Biomed. Anal., 37, 23-33.
17. Jia, L.; Coward, L.C.; Kerstner-Wood, J.; Gorman, G.; Noker, P.; Kitada, S.; Pellecchia, M.P. and Reed, J.C. (2007) Cancer Chemother. Pharmacol., 60, 570-80.
18. Song, M.; Hang, T.J.; Zhang, Z.X; Du, R. and Chen, J. (2005) J. Chromatogr., 827, 205-209.
19. Jia, L.; Young, X. and Guo, W. (1999) J. Pharm. Sci., 88, 981-986.
20. Esser, C.K.; Black, R.M. and Langen, D.V. (2004) Pharm. Discov., Nov./ Dec., 26-32.
21. Thakker, D.R.; Yaqi, H.; Lu, A.Y.; Levin, W. and Conney, A.H. (1976) Proc. Natl. Acad. Sci. USA, 73, 3381-3385.
22. Wu, D.F.; Yu, Y.W.; Tang, Z.M. and Wang, M.Z. (1986) Clin. Pharmacol. Ther., 39, 613-8.
23. Shelly, M.D.; Hartley, L.; Groundwater, P.W. and Fish, R.G. (2000) Anti-Cancer Drugs, 11, 209-216.
24. FDA Guidance for Industry. (1999) In vivo drug metabolism/drug interaction studies-study design, data analysis, and recommendations for dosing and labeling. www.fda.gov/cder/guidance.
25. U.S. FDA Guidance for Industry (2005) Safety Testing of Drug Metabolites. www.fda.gov/cder/guidance.
26. U.S. FDA (2002) Guideline for Metabolism Studies and for Selection of Residues for Toxicological Testing. www.fda.gov/cvm/guidance/ guideline3ptl.html
27. U.S. Environmental Protection Agency. (1997) Health Effects Test Guidelines OPPTS 870.7485 Metabolism and Pharmacokinetics. www.epa.gov/ epahome/research.htm
28. Jia, L.; Schweikart, K.; Tomaszewski, J.; Reed, J.; Ames, M.; Page, J.; Noker, P. and Munn, D. (2007) Food Chem. Toxicol., (in press),
29. Humphreys, W.G. and Unger, S.E. (2006) Chem. Res. Toxicol., 19, 1564-1569.
30. Smith, D.A. and Obach, R.S. (2005) Drug Metab. Dispos., 33, 1409-1417.
31. Hastings, K.L.; El-Hage, J.; Jacobs, A.; Leighton, J.; Morse, D. and Osterberg, R. (2003) Toxicol. Appl. Pharmacol., 190, 91-92.
32. Lin, J.H. (1995) Drug Metab. Dispos., 23, 1008-1021.
33. Jia, L. and Blantz, R.C. (1998) Eur. J. Pharmacol., 354, 33-41.
34. U.S. FDA Guidance for Industry (2005) Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. www.fda.gov/eder/guidance.
35. Lin, Y.S.; Lockwood, G.F.; Graham, M.A.; Brian, W.R.; Loi, C.M.; Dobrinska, M.R.; Shen, D.D.; Watkins, P.B.; Wilkinson, G.R.; Kharasch, E.D., and Thummel, K.E. (2001) Pharmacogenetics, 11, 791-791.
36. Liu, X.D. and Chen, J. (2001) Eur. J. Drug Metab. Pharmacokinet., 26, 249-255.
37. Khan, J.K.; Montaseri, H.; Poglod, M.; Bu, H.Z.; Zuo, Z.; Salama, S.M.; Daneshtalab, M. and Micetich, R. (2000) Antimicrob. Agents Chemother., 44, 910-915.
38. Chiou, W.L.; Jeong, H.Y.; Chung, S.M. and Wu, T.C. (2000) Pharm. Res., 17, 135-140.
39. Olson, H.; Betton, G.; Robinson, D.; Thomas, K.; Monro, A.; Kolaja, G.; Lilly, P.; Sanders, J.; Sipes, G.; Braken, W.; Dorato, M.; Van Deun, K.; Smith, P.; Berger, B. and Heller, A. (2000) Regul. Tax. Pharm., 32, 56-67.
40. Shen, D.D.; Kunze, K.L. and Thummel, K.E. (1997) Adv. Drug Del. Rev., 27, 99-127.
41. Ilett, K.F.; Tee, L.B.G.; Reeves, P.T. and Minchin, R.F., (1990) Pharmacol. Ther., 46, 67-93.
42. Lin, J.H.; Chiba, M.; Chen, I.W.; Nishime, J.A.; deLuna, F.A.; Yamazaki, M. and Lin, Y.J. (1999) Drug Metab. Dispos., 10, 1187-1193.
43. Lin, J.H.; Chiba, M. and Baile, T.A. (1999) Pharm. Rev., 51, 135-157.
44. Beaumont, K.; Harper, A.; Smith, D.A. and Bennett, J. (2000) Eur. J. Pharm. Sci., 12, 41-50.
45. Sparreboom, A.; Van Asperen, J.; Mayer, U.; Schinkel, A.H.; Smit, J.W.; Meijer, D.K.F.; Borst, P.; Nooijen, W.J.; Beijnen, J.H. and van Tellingen, O. (1997) Proc. Natl. Acad. Sci. USA, 94, 2031-2035.
46. Gottesman, M.M. and Pastan, I. (1993) Annu. Rev. Biochem., 62, 385-427.
47. Kim, R.B.; Wandel, C.; Leake, B.; Cvetkovic, M.; Fromm, M.F.; Dempsey, P.J.; Roden, M.M.; Belas, F.; Chaudhary, A.K.; Roden, D.M.; Wood, A.J.J. and Wilkinson, G.R. (1999) Pharm. Res., 16, 408-414.
48. Hawksworth, G.; Drasar, B.S. and Hill, M.J. (1971) J. Med. Microbiol., 4, 451-459.
49. Kenyon, E.M. and Calabrese, E.J. (1993) Xenobiotica, 4, 373-381.
50. Hill, M.J. and Drasar, B.S. (1975) Gut, 4, 318-323.
51. Upson, D.W. (1990) in Upton's Handbook of Clinical Veterinary Pharmacology, 2nd Edition, Veterinary Medicine Publishing, Lenexa.
52. Kararli, T.T. (1995) Biopharm. Drug Dispos., 5, 351-380.
53. Yamada, A.; Furuya, M.; Akimoto, T.; Maki, T.; Suwa, H. and Ogata, H. (1995) Int. J. Pharm., 119, 1-10.
54. Gardner, N.; Haresign, W.; Spiller, R.; Farraj, N.; Wiseman, J. and Norbury, H. (1996) J. Pharm. Pharmacol., 7, 689-693.