A retrospective analysis of toxicogenomics in the safety assessment of drug candidates

Toxicologic Pathology

Volumn 35, Issue 5, 2007, Pages 621-635

  Foster, William R ^a   Chen, Shen Jue ^a   He, Aiqing ^a   Truong, Amy ^a   Bhaskaran, Vasanthi ^a   Nelson, David M ^a   Dambach, Donna M ^a   Lehman McKeeman, Lois D ^a   Car, Bruce D ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Biomarkers; Drug safety; Microarray; Safety biomarkers; Toxicogenomics; Toxicology; Transcriptomics

Indexed keywords

BIOLOGICAL MARKER;

DOSE RESPONSE; DRUG EFFECT; HISTOPATHOLOGY; MICROSCOPY; NONHUMAN; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SENSITIVITY ANALYSIS; STATISTICAL SIGNIFICANCE; TOXICOGENETICS;

ANIMALS; BIOLOGICAL MARKERS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG TOXICITY; GENE EXPRESSION PROFILING; HUMANS; RETROSPECTIVE STUDIES; RISK ASSESSMENT; SAFETY; TOXICOGENETICS;

EID: 34547236464     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1080/01926230701419063     Document Type: Review

References (19)

1. Abdulla, D., and Renton, K. W. (2005). Beta-adrenergic receptor modulation of the LPS-mediated depression in CYP1A activity in astrocytes. Biochem Pharmacol 69, 741-50.
2. Burczynski, M. E. (2003). An Introduction to Toxicogenomics. CRC Press, Boca Raton, FL.
3. Boverhof, D. R., and Zacharewski, T. R. (2006). Toxicogenomics and risk assessment: Applications and needs. Toxicol Sci 89, 352-60.
4. Car, B. D., Eng, V. M., Everds, N. E., and Bounous, D. I. (2005). Clinical pathology of the rat. In The Laboratory Rat, 2nd ed.(M. A. Suckow, S. H. Weisbroth, and C. L. Franklin, eds.), pp. 127-139, Elsevier Academic Press, London.
5. Critical Path Institute (2006). Institute web site: http://www.c-path. org.
6. Ellinger-Ziegelbauer, B., Stuart, B., Wahle B., Bomann, W., and Ahr, H. J. (2004). Characteristic expression profiles induced by genotoxic carcinogens in rat liver. Toxicol Sci 77, 19-34.
7. Hayes, K. R., Vollrath, A. L., Zastrow, G. M., McMillan, B. J., Craven, M., Jovanovich, S., Rank, D. R., Penn, S., Walisser, J.A., Reddy, J. K., Thomas, R. S., and Bradfield, C. A. (2005). EDGE: a centralized resource for the comparison, analysis, and distribution of toxicogenomic information. Mol Pharmacol 67, 1360-8.
8. Hosack, D. A., Dennis, Jr. G., Sherman, B. T., Lane, H. C., and Lempicki, R. A. (2003). Identifying biological themes within lists of genes with EASE. Genome Biol 4, R70. [published online].
9. International Life Sciences Institute (2006). Available: 〈http://www.ilsi.org/〉.
10. Luhe, A., Suter, L., Ruepp, S., Singer, T., Weiser, T., and Albertini, S. (2005). Toxicogenomics in the pharmaceutical industry: Hollow promises or real benefit? Mut Res 575, 102-115.
11. Li, P. X., Wong, J., Ayed, A., Ngo, D., Brade, A. M., Arrowsmith, C., Austin, R. C., and Klamut, H. J. (2000). Placenta TGF-β is a downstream mediator of the growth arrest and apoptotic resonse of tumor cells to DNA damage and p53 overexpression. J Biol Chem 275, 20127-35.
12. Mattingly, C. J., Rosenstein, M. C., Davis, A. P., Colby, G. T., Forrest, J. N. Jr., and Boyer, J. L. (2006). The Comparative Toxicogenomics Database (CTD): A cross-species resource for building chemical-gene interaction networks. Toxicol Sci 92, 587-95.
13. Norris, A. W., and Kahn, C.R. (2006). Analysis of gene expression in pathophysiological states: Balancing false discovery and false negative rates. Proc Natl Acad Sci USA 103, 649-53.
14. National Research Council (1996). Guide for the Care and Use of Laboratory Animals. National Academy Press, Washington, DC.
15. Salter, H. (2003). Large-scale databases in toxicogenomics. Pharmacogenomics 6, 749-54.
16. US Food and Drug Administration (2004). Challenge and Opportunity on the Critical Path to New Medical Products. Retrieved June 2, 2006, from: 〈http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html〉.
17. US Food and Drug Administration Center for Drug Evaluation and Research (2005). Guidance for Industry: Pharmacogenomics Data Submissions. Retrieved June 2, 2006, from: 〈http://www.fda.gov/cder/guidance/6400fnl.pdf〉.
18. US Food and Drug Administration Center for Drug Evaluation and Research (2006). Retrieved June 2, 2006, from: 〈http://www.fda.gov/cder/genomics/ FAQ.htm〉.
19. Waring, J. F., Jolly, R. A., Ciurlionis, R., Lum, P. Y., Praestgaard, J. T., Morfitt, D. C., Buratto, B., Roberts, C., Schadt, E., and Ulrich, R. G. (2001). Clustering of hepatotoxins based on mechanism of toxicity using gene expression profiles. Toxicol Appl Pharmacol 175, 28-42.