The new revolution in toxicology: The good, the bad, and the ugly

Annals of the New York Academy of Sciences

Volumn 1278, Issue 1, 2013, Pages 11-24

  Davis, Myrtle ^a   Boekelheide, Kim ^b   Boverhof, Darrell R ^c   Eichenbaum, Gary ^d   Hartung, Thomas ^e   Holsapple, Michael P ^f   Jones, Thomas W ^g   Richard, Ann M ^h   Watkins, Paul B ⁱ  

^a NATIONAL CANCER INSTITUTE   (United States)

^b BROWN UNIVERSITY   (United States)

^c DOW CHEMICAL COMPANY   (United States)

^d JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^e JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^f BATTELLE MEMORIAL INSTITUTE   (United States)

^g ELI LILLY AND COMPANY   (United States)

^h U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

ⁱ Hamner University of North Carolina   (United States)

Author keywords

Pharmaceuticals; Testing; Toxicology

Indexed keywords

ALCOHOL; ENDOCRINE DISRUPTOR; XENOBIOTIC AGENT;

ADVERSE OUTCOME; ALCOHOL CONSUMPTION; ARTICLE; CANCER RESEARCH; CARCINOGENICITY; CHEMICAL STRUCTURE; CLINICAL ASSESSMENT TOOL; CLINICAL PRACTICE; COST BENEFIT ANALYSIS; DRUG EXPOSURE; DRUG INDUSTRY; DRUG INFORMATION; DRUG TOLERABILITY; FOOD AND DRUG ADMINISTRATION; GENOTOXICITY; HEALTH CARE ORGANIZATION; HEALTH PROGRAM; HUMAN; IDIOSYNCRATIC HEPATOTOXICITY; INJECTION SITE REACTION; LEGAL ASPECT; LIVER TOXICITY; LONG TERM EXPOSURE; MEDICAL DECISION MAKING; MEDICAL SOCIETY; NONHUMAN; PHARMACEUTICS; RISK ASSESSMENT; RISK MANAGEMENT; SAFETY; SIGNAL TRANSDUCTION; TERATOGENICITY; TOXICITY TESTING; TOXICOLOGY; UNITED STATES;

EID: 84874972649     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/nyas.12086     Document Type: Article

References (59)

1. Committee on Toxicity Testing and Assessment of Environmental Agents, National Research Council. 2011 Toxicity Testing in the 21st Century: A Vision and a Strategy. National Academies Press. Washington D.C.
2. Committee on Breast Cancer and the Environment: The Scientific Evidence, Research Methodology, and Future Directions; Institute of Medicine. 2012. Breast Cancer and the Environment: A Life Course Approach. National Academies Press. Washington D.C.
3. Li, C.I. et al. 2010. Alcohol consumption and risk of postmenopausal breast cancer by subtype: the women's health initiative observational study. J Natl Cancer Inst. 102: 1422-1431.
4. Sand, S., C.J. Portier & D. Krewski 2011. A signal-to-noise crossover dose as the point of departure for health risk assessment. Environ Health Perspect. 119: 1766-1774.
5. Edwards, S.W. & R.J. Preston 2008. Systems biology and mode of action based risk assessment. Toxicol Sci. 106: 312-318.
6. Collins, F.S., G.M. Gray & J.R. Bucher 2008. Toxicology. Transforming environmental health protection. Science 319: 906-907.
7. Firestone, M.R. et al. 2010. The U.S. Environmental Protection Agency Strategic Plan for Evaluating the Toxicity of Chemicals. J. Toxicol. Environ. Health B. Cri. Rev. 13: 139-162.
8. Hamburg, M.A. 2011. Advancing Regulatory Science. Science 331: 987-987.
9. Seidle, T. & M.L. Stephens 2009. Bringing toxicology into the 21st century: A global call to action. Toxicol in vitro. 23: 1576-1579.
10. Stephens, M.L. et al. 2012. Accelerating the development of 21st-century toxicology: outcome of a Human Toxicology Project Consortium workshop. Toxicol. Sci. 125: 327-334.
11. Committee on Improving Risk Analysis Approaches Used by the U.S. EPA, National Research Council. 2009. Science and Decisions: Advancing Risk Assessment. National Academies Press. Washington D.C.
12. Mitchell, R.T. et al. 2012. Do phthalates affect steroidogenesis by the human fetal testis? Exposure of human fetal testis xenografts to di-n-butyl phthalate. J Clin Endocrinol Metab. 97: E341-348.
13. Heger, N.E. et al. 2012. Human fetal testis xenografts are resistant to phthalate-induced endocrine disruption. Environ Health Perspect. 120: 1137-1143.
14. Anson, B.D., K.L. Kolaja & T.J. Kamp 2011. Opportunities for use of human iPS cells in predictive toxicology. Clin Pharmacol Ther. 89: 754-758.
15. Boverhof, D.R. 2009. I. Evaluation of a toxicogenomic approach to the local lymph node assay (LLNA). Toxicol Sci. 107: 427-539.
16. Ku, H.O. et al. 2011. Pathway analysis of gene expression in local lymph nodes draining skin exposed to three different sensitizers. J Appl Toxicol. 31: 455-462.
17. Adenuga, D. et al. 2012. Differential gene expression responses distinguish contact and respiratory sensitizers and nonsensitizing irritants in the local lymph node assay. Toxicol Sci. 126: 413-425.
18. Aeby P. et al. 2010. Identifying and characterizing chemical skin sensitizers without animal testing: Colipa's research and method development program. Toxicol In Vitro. 24: 1465-1473.
19. Abassi, Y.A., B. Xi, et al. 2012. Dynamic monitoring of beating periodicity of stem cell-derived cardiomyocytes as a predictive tool for preclinical safety assessment. Br. J. Pharmacol. 165: 1424-1441.
20. Bolt, H.M. & J.G. Hengstler 2008. Most cited articles in the Archives of Toxicology: the debate about possibilities and limitations of in vitro toxicity tests and replacement of in vivo studies. Arch. Toxicol. 82: 881-883.
21. Brendler-Schwaab, S.Y., P. Schmezer, et al. 1994. Cells of different tissues for in vitro and in vivo studies in toxicology: Compilation of isolation methods. Toxicol. In Vitro 8: 1285-1302.
22. Charlton, J.A. & N.L. Simmons 1993. Established human renal cell lines: Phenotypic characteristics define suitability for use in in vitro models for predictive toxicology. Toxicol. In Vitro 7: 129-136.
23. Cheng, H. & T. Force 2010. Molecular mechanisms of cardiovascular toxicity of targeted cancer therapeutics. Circ. Res. 106: 21-34.
24. Clark, D.L., P.A. Andrews, et al. 1999. Predictive value of preclinical toxicology studies for platinum anticancer drugs. Clin. Cancer Res. 5: 1161-1167.
25. Davila, J.C., R.J. Rodriguez, et al. 1998. Predictive value of in vitro model systems in toxicology. Annu. Rev. Pharmacol. Toxicol. 38: 63-96.
26. Dickens, H., A. Ullrich, et al. 2008. Anticancer drug cis-4-hydroxy-L-proline: correlation of preclinical toxicology with clinical parameters of liver function. Mol. Med. Report 1: 459-464.
27. Ehrich, M. 2003. Bridging the gap between in vitro and in vivo toxicology testing. Altern. Lab. Anim. 31: 267-271.
28. Eschenhagen, T., T. Force, et al. 2011. Cardiovascular side effects of cancer therapies: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur. J. Heart Fail. 13: 1-10.
29. Fagerland, J. A., H. G. Wall, et al. 2012. Ultrastructural analysis in preclinical safety evaluation. Toxicol Pathol. 40: 391-402.
30. Fielden, M.R., B.P. Eynon, et al. 2005. A gene expression signature that predicts the future onset of drug-induced renal tubular toxicity. Toxicol. Pathol. 33: 675-683.
31. Fielden, M.R. & K.L. Kolaja 2008. The role of early in vivo toxicity testing in drug discovery toxicology. Expert Opin. Drug Saf. 7: 107-110.
32. Feldman, A.M., W.J. Koch, et al. 2007. Developing strategies to link basic cardiovascular sciences with clinical drug development: another opportunity for translational sciences. Clin. Pharmacol. Ther. 81: 887-892.
33. Force, T., K. Kuida, et al. 2004. Inhibitors of protein kinase signaling pathways: emerging therapies for cardiovascular disease. Circulation 109: 1196-1205.
34. Force, T., C.M. Pombo, et al. 1996. Stress-activated protein kinases in cardiovascular disease. Circ. Res. 78: 947-953.
35. Force, T. & J.R. Woodgett 2009. Unique and overlapping functions of GSK-3 isoforms in cell differentiation and proliferation and cardiovascular development. J. Biol. Chem. 284: 9643-9647.
36. Fukumoto, J. & N. Kolliputi 2012. Human lung on a chip: innovative approach for understanding disease processes and effective drug testing. Front. Pharmacol. 3: 205.
37. Ganter, B., S. Tugendreich, et al. 2005. Development of a large-scale chemogenomics database to improve drug candidate selection and to understand mechanisms of chemical toxicity and action. J. Biotechnol. 119: 219-244.
38. Geenen, S., P.N. Taylor, et al. 2012. Systems biology tools for toxicology. Arch. Toxicol. 86: 1251-1271.
39. Higgins, J., M.E. Cartwright, et al. 2012. Progressing preclinical drug candidates: strategies on preclinical safety studies and the quest for adequate exposure. Drug Discov. Today 17: 828-836.
40. Holsapple, M.P., C.A. Afshari, et al. 2009. Forum series: the "vision" for toxicity testing in the 21st century: promises and conundrums. Toxicol. Sci. 107: 307-308.
41. Huh, D., D.C. Leslie, et al. 2012. A human disease model of drug toxicity-induced pulmonary edema in a lung-on-a-chip microdevice. Sci. Transl. Med. 4: 159ra147.
42. Kim, H.J., D. Huh, et al. 2012. Human gut-on-a-chip inhabited by microbial flora that experiences intestinal peristalsis-like motions and flow. Lab Chip 12: 2165-2174.
43. Kluwe, W.M. 1995. The complementary roles of in vitro and in vivo tests in genetic toxicology assessment. Regul. Toxicol. Pharmacol. 22: 268-272.
44. MacDonald, J.S. & R.T. Robertson 2009. Toxicity testing in the 21st century: a view from the pharmaceutical industry. Toxicol. Sci. 110: 40-46.
45. Marchan, R., H.M. Bolt, et al. 2012. Systems biology meets toxicology. Arch. Toxicol. 86: 1157-1158.
46. Marin, J.J., O. Briz, et al. 2009. Hepatobiliary transporters in the pharmacology and toxicology of anticancer drugs. Front. Biosci. 14: 4257-4280.
47. Marks, L., S. Borland, et al. 2012. The role of the anaesthetised guinea-pig in the preclinical cardiac safety evaluation of drug candidate compounds. Toxicol. Appl. Pharmacol. 263: 171-183.
48. Marx, U., H. Walles, et al. 2012. "Human-on-a-chip" developments: a translational cutting-edge alternative to systemic safety assessment and efficiency evaluation of substances in laboratory animals and man? Altern. Lab Anim. 40: 235-257.
49. Meek, B. & J. Doull 2009. Pragmatic challenges for the vision of toxicity testing in the 21st century in a regulatory context: another Ames test? ... or a new edition of "the Red Book"? Toxicol. Sci. 108: 19-21.
50. Mikaelian, I., M. Scicchitano, et al. 2013. Frontiers in preclinical safety biomarkers: microRNAs and messenger RNAs. Toxicol. Pathol. 41: 18-31.
51. Olaharski, A.J., H. Uppal, et al. 2009. In vitro to in vivo concordance of a high throughput assay of bone marrow toxicity across a diverse set of drug candidates. Toxicol. Lett. 188: 98-103.
52. Olson, H., G. Betton, et al. 2000. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul. Toxicol. Pharmacol. 32: 56-67.
53. Pleil, J.D., M.A. Williams, et al. 2012. Chemical Safety for Sustainability (CSS): human in vivo biomonitoring data for complementing results from in vitro toxicology--a commentary. Toxicol. Lett. 215: 201-207.
54. Polson, A.G. & R.N. Fuji 2012. The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients. Br. J. Pharmacol. 166: 1600-1602.
55. Rennard, S.I., D.M. Daughton, et al. 1990. In vivo and in vitro methods for evaluating airways inflammation: implications for respiratory toxicology. Toxicology 60: 5-14.
56. Robinson, J.F., P.T. Theunissen, et al. 2011. Comparison of MeHg-induced toxicogenomic responses across in vivo and in vitro models used in developmental toxicology. Reprod. Toxicol. 32: 180-188.
57. Sai, K. & Y. Saito 2011. Ethnic differences in the metabolism, toxicology and efficacy of three anticancer drugs. Expert Opin. Drug Metab. Toxicol. 7: 967-988.
58. Warner, C.M., K.A. Gust, et al. 2012. A systems toxicology approach to elucidate the mechanisms involved in RDX species-specific sensitivity. Environ. Sci. Technol. 46: 7790-7798.
59. Yang, B. & T. Papoian 2012. Tyrosine kinase inhibitor (TKI)-induced cardiotoxicity: approaches to narrow the gaps between preclinical safety evaluation and clinical outcome. J. Appl. Toxicol. 32: 945-951.