The role of genetic toxicology in drug discovery and optimization

Current Drug Metabolism

Volumn 9, Issue 9, 2008, Pages 978-985

  Custer, Laura L ^a   Sweder, K S ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

Author keywords

Clastogenicity; Comet; Computational toxicology; Decision tree; Drug safety; Genotoxicity screening; Mutagenicity; Pig a

Indexed keywords

CLASTOGEN; DRUG; GREEN FLUORESCENT PROTEIN; GROWTH ARREST AND DNA DAMAGE INDUCIBLE PROTEIN 45; GROWTH ARREST AND DNA DAMAGE INDUCIBLE PROTEIN 45 ALPHA; RAD54 PROTEIN; UNCLASSIFIED DRUG; MUTAGENIC AGENT;

AMES TEST; BACTERIAL MUTATION; CARCINOGENICITY; COMET ASSAY; COMPUTER PREDICTION; COMPUTER PROGRAM; DECISION SUPPORT SYSTEM; EXPERT SYSTEM; GENETIC TOXICOLOGY; GENOTOXICITY; HUMAN; MATHEMATICAL MODEL; MICRONUCLEUS TEST; MUTAGEN TESTING; MUTAGENICITY; NONHUMAN; PIG A LOCUS; PROCESS OPTIMIZATION; QUANTITATIVE STRUCTURE ACTIVITY RELATION; REVIEW; SCREENING TEST; SOS CHROMOTEST; TOXICITY TESTING; YEAST DEL ASSAY; ANIMAL; BACTERIUM; CHEMISTRY; COMPUTER SIMULATION; DRUG DESIGN; DRUG EFFECT; DRUG SCREENING; GENETICS; STRUCTURE ACTIVITY RELATION;

ANIMALS; BACTERIA; COMPUTER SIMULATION; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; HUMANS; MUTAGENICITY TESTS; MUTAGENS; PHARMACEUTICAL PREPARATIONS; STRUCTURE-ACTIVITY RELATIONSHIP;

EID: 60749089481     PISSN: 13892002     EISSN: None     Source Type: Journal    
DOI: 10.2174/138920008786485191     Document Type: Review

References (45)

1. ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Organization). S2(R1): Step 3 draft guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. July 2008, http://www.ich.org/cache/compo/502-272-1.html#S2.
2. Kavlock, R.J.; Ankley, G.; Blancato, J.; Breen, M.; Conolly, R.; Dix, D.; Houck, K.; Hubal, E.; Judson, R.; Rabinowitz, J.; Richard, A.; Setzer, R.W.; Shah, I.; Villeneuve, D. and Weber, E. (2008) Toxicol. Sci., 103, 14-27.
3. Hamann, L.G.; Manfredi, M.C.; Sun, C.; Krystek, J.S.R.; Huang, Y.; Bi, Y.; Augeri, D. J.; Wang, T.; Zou, Y.; Betebenner, D.A.; Fura, A.; Seethala, R.; Golla, R.; Kuhns, J. E.; Lupisella, J.A.; Darienzo, C.J.; Custer, L.L.; Price, J.L.; Johnson, J.M.; Biller, S. A.; Zahler, R. and Ostrowski, J. (2007) Bioorg. Med. Chem. Lett., 17, 1860-1864.
4. Kruhlak, N.L.; Contrera, J.F.; Benz, R.D. and Matthews, E.J. (2007) Adv. Drug Deliv. Rev., 59, 43-55.
5. Kier, L.B. and Hall, L.H. (1990) Pharm. Res., 7, 801-807.
6. Ashby, J. and Tennant, R.W. (1988) Mutat. Res., 204, 17-115.
7. Greene, N.; Judson, P.N.; Langowski, J.J. and Marchant, C.A. (1999) SAR QSAR Environ. Res., 10, 299-314.
8. Contrera, J.F.; Matthews, E.J.; Kruhlak, N.L. and Benz, R.D. (2008) Toxicol. Mechan. Methods, 18, 207-216.
9. Jacobson-Kram, D. and Contrera, J.F. (2007) Toxicol. Sci., 96, 16-20.
10. Contrera, J.F.; Matthews, E.J.; Kruhlak, N.L. and Benz, R.D. (2005) Regul. Toxicol. Pharmacol., 43, 313-323.
11. FDA/MultiCASE QSAR Seminar May 19, 2008. FDA White Oak Facility in Silver Spring, MD.
12. Burke, D. A.; Wedd, D. J. and Burlinson, B. (1996) Mutagenesis 11, 201-205.
13. Kado, N.Y.; Langley, D. and Eisenstadt, E. (1983) Mutat. Res. Lett., 121, 25-32.
14. Aubrecht, J.; Osowski, J.J.; Persaud, P.; Cheung, J.R.; Ackerman, J.; Lopes, S.H. and Ku, W.W. (2007) Mutagenesis, 22, 335-42
15. Gilchrist, J.E.; Campbell, J.E.; Donnelly, C.B.; Peeler, J.T. and Delaney, J.M. (1973) Appl. Environ. Microbiol., 25, 244-252.
16. Flückiger-Isler, S.; Baumeister, M.; Braun, K.; Gervais, V.; Hasler-Nguyen, N.; Reimann, R.; Van Gompel, J.; Wunderlich, H.G. and Engelhardt, G. (2004) Mutat. Res., 558, 181-197.
17. Gee, P.; Sommers, C.H.; Melick, A.S.; Gidrol, X.M.; Todd, M.D.; Burris, R.B.; Nelson, M.E.; Klemm, R.C. and Zeiger, E. (1998) Mutat. Res., 412, 115-130.
18. Oda, Y.; Nakamura, S.; Oki, I.; Kato, T. and Shinagawa, H. (1985) Mutat. Res., 147, 219-229.
19. Hofnung, M. and Quillardet, P. (1986) Mutagenesis, 1, 319-330.
20. Quillardet, P. and Hofnung, M. (1993) Mutat. Res., 297, 235-279.
21. Miller, C.; Thomsen, L.E.; Gaggero, C.; Mosseri, R.; Ingmer, H. and Cohen, S.N. (2004) Science, 305, 1629-1631.
22. Parry, E.M.; Parry, J.M.; Corso, C.; Doherty, A.; Haddad, F.; Hermine, T.F.; Johnson, G.; Kayani, M.; Quick, E.; Warr, T. and Williamson, J. (2002) Mutagenesis, 17, 509-521.
23. Fenech, M. (2000) Mutat. Res., 455, 81-95.
24. Bryce, S.M.; Bemis, J.C.; Avlasevich, S.L. and Dertinger, S.D. (2007) Mutat. Res., 630, 78-91.
25. Frieauff, W.; Potter-Locher, F.; Cordier, A. and Suter, W. (1998) Mutat. Res., 413, 57-68.
26. Smolewski, P.; Ruan, Q.; Vellon, L. and Darzynkiewicz, Z. (2001) Cytometry, 45, 19-26.
27. Avlasevich, S.L.; Bryce, S.M.; Cairns, S.E. and Dertinger, S.D. (2006) Environ. Mol. Mutagen., 47, 56-66.
28. Bryce, S.M.; Avlasevich, S.L.; Bemis, J.C.; Lukamowicz, M.; Elhajouji, A.; Van Goethem, F.; De Boeck, M.; Beerens, D.; Aerts, H.; Van Gompel, J.; Collins, J.E.; Ellis, P.C.; White, A.T.; Lynch, A.M. and Dertinger, S.D. (2008) Mutat. Res., 650, 181-195.
29. Lorge, E.; Lambert, C.; Gervais, V.; Becourt-Lhote, N.; Delongeas, J.-L. and Claude, N. (2007) Toxicol. Sci., 96, 214-217.
30. Matsushima, T.; Hayashi, M.; Matsuoka, A.; Ishidate, M. Jr.; Miura, K.F.; Shimizu, H.; Suzuki, Y.; Morimoto, K.; Ogura, H.; Mure, K.; Koshi, K. and Sofuni, T. (1999) Mutagenesis, 14, 569-580.
31. Kiskinis, E.; Suter, W. and Hartmann, A. (2002) Mutagenesis, 17, 37-43.
32. Hartmann, A.; Schumacher, M.; Plappert-Helbig, U.; Lowe, P.; Suter, W. and Mueller, L. (2004) Mutagenesis, 19, 51-59.
33. Schiestl, R.H.; Gietz, R.D.; Mehta, R.D. and Hastings, P.J. (1989) Carcinogenesis, 10, 1445-1455
34. Brennan, R.J. and Schiestl, R.H. (2004) Methods Mol. Biol., 262, 111-124.
35. Ku, W.W.; Aubrecht, J.; Mauthe, R.J.; Schiestl, R.H. and Fornace, A.J. Jr. (2007) Toxicol. Sci., 99, 20-25.
36. Cahill, P.A.; Knight, A.W.; Billinton, N.; Barker, M.G.; Walsh, L.; Keenan, P.O.; Williams, C.V.; Tweats, D.J. and Walmsley, R.M. (2004) Mutagenesis, 19, 105-119.
37. Hastwell, P.W.; Chai, L.-L.; Roberts, K.J.; Webster, T.W.; Harvey, J.S.; Rees, R.W. and Walmsley, R.M. (2006) Mutat. Res., 607, 160-175.
38. Van Gompel, J.; Woestenborghs, F.; Beerens, D.; Mackie, C.; Cahill, P.A.; Knight, A.W.; Billinton, N.; Tweats, D.J. and Walmsley, R.M. (2005) Mutagenesis, 20, 449-454.
39. Bryce, S.M.; Bemis, J.C.; Dertinger, S.D. (2008) Environ. Mol. Mutagen., 49, 256-264.
40. Iida, Y.; Takeda, J.; Miyata, T.; Inoue, N.; Nishimura, J.; Kitani, T.; Maeda, K. and Kinoshita, T. (1994) Blood, 83, 3126-3131.
41. Greene, N. (2002) Adv. Drug Deliv. Rev., 54, 417-431.
42. Sanderson, D. M. and Earnshaw, C.G. (1991) Hum. Exp. Toxicol., 10, 261-273.
43. Matthews, E.J. and Contrera, J.F. (1998) Regul. Toxicol. Pharmacol., 28, 242-264.
44. Contrera, J.F.; Matthews, E.J.; Kruhlak, N.L. and Benz, R.D. (2008) Toxicol. Mechan. Methods, 18, 207-216.
45. Bryce, S.; Bemis, J. and Dertinger, S. (2008) Environ. Mol. Mutagen., 49, 256-264.