Clear path: towards an evidence-based toxicology (EBT)

1 Evidence-Based Medicine Working Group . Evidence-based medicine. A new approach to teaching the practice of medicine . J Am Med Assoc 1992; 268: 2420 – 2425 .

2 Guzelian PS  Victoroff MS  Halmes NC  James RC  Guzelian CP  . Evidence-based toxicology: a comprehensive framework for causation . Hum Exp Toxicol 2005; 24: 161 – 201 .

3 Briggs R  Stuart G  . What sticks: why most advertising fails and how to guarantee yours succeeds. Chicago : Kaplan Publishing ; 2006.

4 Hoffmann S  Hartung T  . Toward an evidence-based toxicology . Hum Exp Toxicol 2006; 25: 497 – 513 .

5 Griesinger C  . Foundations of an evidence-based toxicology. Proceedings of the First International Forum Towards Evidence-Based Toxicology, Conference Centre Spazio Villa Erba, Como, Italy, 15−18 October 2007.

6 Eddy DM  . Evidence-based medicine: a unified approach . Health Aff 2005; 24: 9 – 17 .

7 Slovic P  Finucane M  Peters E  MacGregor D  . Risk as analysis and risk as feelings: some thoughts about affect, reason, risk and rationality . Risk Anal 2004; 24: 311 – 322 .

8 Rudén C  . The use and evaluation of data in 29 trichloroethylene carcinogen datasets . Regul Toxicol Pharmacol 2001; 34: 3 – 16 .

9 Rudén C  . Interpretations of primary carcinogen data in 29 trichloroethylene risk assessments . Toxicology 2001; 169: 209 – 225 .

10 Rudén C  . The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments. The trichloroethylene example . Regul Toxicol Pharmacol 2002; 35: 80 – 94 .

11 Rudén C  . Acrylamide cancer risk – expert assessments and the public debate . Food Chem Toxicol 2004; 42: 335 – 349 .

12 Rudén C  . Science and policy in risk assessments of chlorinated ethenes . Ann N Y Acad Sci 2006; 1076: 191 – 206 .

13 Rudén C  . Principles and practices of health risk assessment under current EU regulations . Regul Toxicol Pharmacol 2006; 44: 14 – 23 .

December 11, 1974 [accessed 23.12.08].

16 Straus SE  McAlister DC  . Evidence-based medicine: a commentary on common criticisms . Can Med J 2000; 163: 837 – 841 .

17 Isaacs D  Fitzgerald D  . Seven alternatives to evidence based medicine . Br Med J 1999; 319: 1618 .

18 Villanueva-Russell Y  . Evidence-based medicine and its implications for the profession of chiropractic . Soc Sci Med 2005; 60: 545 – 561 .

19 Sackett DL  Rosenberg WM  Gray JA  Haynes RB  Richardson WS  . Evidence based medicine: what it is and what it isn't . Br Med J 1996; 312: 71 – 72 .

22 Rudén C  Hansson SO  . Evidence-based toxicology: ‘sound science’ in new disguise . Int J Occup Environ Health 2008; 14: 299 – 306 .

23 Rudén C  . Scrutinizing three trichloroethylene cancer classifications in the European Union – implications for the risk assessment process . Int J Toxicol 2002; 21: 441 – 450 .

24 Rudén C  . Scrutinizing ACGIH risk assessments: the trichloroethylene case . Am J Ind Med 2003; 44: 207 – 217 .

25 Rudén C  . Science and transscience in carcinogen risk assessment – the European Union regulatory process for trichloroethylene . J Toxicol Environ Health 2003; 6: 257 – 277 .

26 Guzelian PS  . Evidence-based toxicology: call for papers . Hum Exp Toxicol 2007; 26: 5 – 7 .

27 Egilman DS  Bohme SR  . Over a barrel: corporate corruption of science and its effects on workers and the environment . Int J Occup Environ Health 2005; 11: 331 – 337 .

28 Office of Technology Assessment . Assessment of technologies for determining cancer risks from the environment. Washington, DC : U.S. Congress, Office of Technology Assessment ; 1981.

29 James RC  . Risk assessment. In: Industrial Toxicology: Safety and Health Applications in the Workplace. Williams, P, Burson, J (Eds.), New York, NY : Van Nostrand Rheinhold ; 1985. pp. 369–398.

30 USEPA. Guidelines for carcinogen risk assessment. Fed Reg 1986; 51: 33992–34003.

31 Gehring PJ  . Are negative toxicological data suspect: an epilog . Regul Toxicol Pharmacol 1969; 9: 53 – 55 .

32 Barnard RC  . Scientific method and risk assessment . Regul Toxicol Pharmacol 1994; 19: 211 – 218 .

33 Paustenbach DJ  . The practice of health risk assessment in the U.S. (1975-1995): how the U.S. and other countries can benefit from that experience . Hum Ecol Risk Assess 1995; 1: 29 – 79 .

34 Lovell DP  Thomas G  . Quantitative risk assessment and the limitations of the linearized multistage model . Hum Exp Toxicol 1996; 15: 87 – 104 .

35 Crump KS  . The linearized multistage model and the future of quantitative risk assessment . Hum Exp Toxicol 1996; 15: 787 – 798 .

36 Pitot HC  Dragan YP  . Chemical carcinogenesis. In: Casarett and Doull’s toxicology. The basic science of poisons. Fifth Edition. Klaassen, CD (Ed.), New York, NY : McGraw Hill ; 1996. pp. 201–267.

37 Popper KR  . The logic of scientific discovery. New York, NY : Routledge ; 1980.

38 Federal Register 1985; 51: 33998 .

39 Guzelian PS  Guzelian CP  . Authority-based explanation . Science 2004; 303: 1468 – 1469 .

40 Garabrant DH  James RC  . Trichloroethylene and cancer in humans: recognizing the need for an evidence based analysis . Toxicology 2005; 212: 80 – 84 .

41 Cappiello D;  Snyder M;  . Air, cancer risk linked in some Houston areas / White Advocates Tighter Regulations To Reduce Pollution. Houston Chronicle Date: THU 01/13/2005 Section: A Page: 1 Edition: 3 STAR).

42 NAS (National Academy of Science) . Risk assessment in the federal government. Washington, DC : National Research Council. National Academy Press ; 1983.

43 Portier C  . Toxicological decision-making on hazards and risks – status quo and way forward . J Psychopharmacol 2009; 23: xx – xx .

44 Committee on Improving Risk Analysis Approaches Used by the U.S. EPA. National Research Council of the National Academies. Science and Decisions: Advancing Risk Assessment. Washington, DC: The National Academies Press; 2008.

January, 2006 [accessed 23.12.08].

46 Guidelines for carcinogen risk assessment. EPA/630/P-03/001F, March 2005.

47 Squire RA  . Carcinogenicity testing and safety assessment . Fundam Appl Toxicol 1984; 4: S326 – S334 .

48 Ashby J  Doerrer NG  Flamm FG  Harris JE  Hughes DH  Johannsen FR  . A scheme for classifying carcinogens . Regul Toxicol Pharmacol 1990; 12: 270 – 295 .

49 NRC (National Research Council) . Improving risk communication. Committee on risk perception and communication. Washington, DC : National Academy Press ; 1989.

51 Gargas ML  Finley BL  Paustenbach DJ  Long TF  . Environmental Health Risk Assessment: Theory and Practice. In: General and Applied Toxicology. Ballantyne, B, Marrs, TC, Syversen, T (Eds.), New York, NY : Grove's Dictionaries Inc.; 2000. pp. 1749–1809.

52 Hackam DG  . Translating animal research into clinical benefit. Poor methodological standards in animal studies mean that positive results may not translate to the clinical domain . Br Med J 2007; 334: 163 – 164 .

www.fda.gov/cder/livertox/meeting2001.htm#Drug-Induced February 2001 [accessed 29.12.08].

54 Müller L  . In vitro genotoxicity tests to detect carcinogenicity: a systematic review . Hum Exp Toxicol 2009; 23: xx – xx .

55 Holsapple MP;  Afshari CA;  Lehman-McKeeman LD;  . Forum Series: The ‘vision’ for toxicity testing in the 21st century: promises and conundrums. Toxicol Sci 2008; Advance Access published on December 9, 2008, doi: 10.1093/toxsci/kfn258.

57 Griesinger C  . Comparing medicine with toxicology – a mapping of knowledge creation, concepts and basic epistemology . Hum Exp Toxicol 2009; 23: xx – xx .

58 Guzelian P  Quattrochi L  Karch N  Aylward L  Kaley R  . Does dioxin exert toxic effects in humans at or near current background body levels?: an evidence-based conclusion . Hum Exp Toxicol 2006; 25: 99 – 105 .

59 Ong EK  Glantz AS  . Constructing ‘sound science’ and ‘good epidemiology’: tobacco, lawyers, and public relations firms . Am J Public Health 2001; 91: 1749 – 1757 .

60 Greene SL  Wood DM  Gawarammana IB  Warren-Gash C  Drake N  Jones AL  . Improvement in the management of acutely poisoned patients using an electronic database, prospective audit and targeted educational intervention . Postgrad Med J 2008; 84: 603 – 608 .

61 Health Risks from Dioxin and Related Compounds . Evaluation of the EPA Reassessment. Committee on EPA's Exposure and Human Health Reassessment of TCDD and Related Compounds. National Research Council , 2006.