References

EBM

• Haynes RB, Sackett DL, Gray JM, Cook DJ, Guyatt GH. Transferring evidence from research into practice: 1. The role of clinical care research evidence in clinical decisions. ACP Journal Club 1996; 125: A14-A16.
• Sackett DL, Haynes RB. The architecture of diagnostic research. British Medical Journal 2002; 324: 539-541.
• Straus SE, McAlister FA. Evidence-based medicine: a commentary on common criticisms. Canadian Medical Association Journal 2000; 163: 837-841.
• Haynes RB, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. Evidence Based Medicine 2002; 7: 36-38.
• Hunink M, Glasziou P, Siegel J et al. Decision making in health and medicine: integrating evidence and values. New York: Cambridge University Press 2001.
• Hawkins RC. The Evidence Based Medicine Approach to Diagnostic Testing: practicalities and limitations. Clinical Biochemical Reviews 2005; 26: 7-18.

EBT

• Buckley NA, Smith AJ. Evidence-based medicine in toxicology: where is the evidence? The Lancet 1996; 347: 1067-1069.
• Guzelian PS, Guzelian CP. Authority-based explanation. Science 2004; 303: 1468-1469.
• Hoffmann S, Hartung T. Diagnosis: toxic! - Trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations. Toxicological Sciences 2005; 85: 422-428.
• Hoffmann S, Hartung T. Toward an evidence-based toxicology. Human and Experimental Toxicology 2006; 25: 497-513.
• Guzelian PS, Victoroff MS, Halmes NC, Janes RC, Guzelian CP. Evidence-based toxicology: a comprehensive framework for causation. Human and Experimental Toxicology 2005; 24: 161-201.
• 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. Human and Experimental Toxicology 2006; 25: 99-105.

Quality assessment

• Phillips B, Ball C, Sackett DL et al. Oxford Centre for Evidence-based Medicine: Levels of Evidence. http://www.cebm.net/levels_of_evidence.asp . 2001.
• Meade MO, Richardson WS. Selecting and Appraising Studies for a Systematic Review. Annals of Internal Medicine 1997; 127: 531-537.
• Whiting P, Rutjes AW, Reitsma J, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology 2003; 3: 25.
• Whiting P, Rutjes AW, Dinnes J, Reitsma JB, Bossuyt PM, Kleijnen J. A systematic review finds that diagnostic reviews fail to incorporate quality despite available tools. |Journal of Clinical Epidemiology 2005; 58: 1-12.
• Bossuyt PM, Reitsma JB, Bruns DE et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. British Medical Journal 2003; 326: 41-44.
• Coecke S, Balls M, Bowe G, Davis J, Gstraunthaler G, Hartung T, Nay R, Merten OW, Price A, Schechtmann L, Stacey G, Stokes W, Patlewicz G (2005). Guidance on good cell culture practice. A report of the second ECVAM task force on good cell culture practice. Alternatives to Laboratory Animals 33, 261-87.

Statistics

• Ioannidis JP. Why most published research findings are false. Public Library of Science Medicine 2005; 2: 696-701.
• Bender R, Lange S. Adjusting for multiple testing--when and how? Journal of Clinical Epidemiology 2001; 54: 343-349.

Systenatic reviews

• Horvath AR, Pewsner D. Systematic reviews in laboratory medicine: principles, processes and practical considerations. Clinica Chimica Acta 2004; 342: 23-39.

Test assessment

• OECD. Guidance document on the validation and international acceptance of new or updated test methods for hazard identification. 1-96. 2005. Paris, Organisation for Economic Cooperation and Development. Environmental Health and Safety Monograph Series on Testing and Assessment No. 34.
• Hoffmann S, Cole T, Hartung T. Skin irritation: prevalence, variability and regulatory classification of existing in vivo data from industrial chemicals. Regulatory Toxicology and Pharmacology 2005; 41: 159-166.
• Gaylor DW. Are tumor incidence rates from chronic bioassays telling us what we need to know about carcinogens? Regulatory Toxicology and Pharmacology 2005; 41: 128-133.
• Knottnerus JA, van Weel C, Muris JW. Evaluation of diagnostic procedures. British Medical Journal 2002; 324: 480.
• Knottnerus JA, Muris JW. Assessment of the accuracy of diagnostic tests: the cross-sectional study. Journal of Clinical Epidemiology 2003; 56: 1118-1128.
• Ennever FK, Lave LB. Implications of the lack of accuracy of the lifetime rodent bioassay for predicting human carcinogenicity. Regulatory Toxicology and Pharmacology 2003; 38: 52-57.
• Lave LB, Ennever FK, Rosenkranz H, Omenn GS. Information value of the rodent bioassay. Nature 1988; 336: 631-633.
• Purchase IFH. Inter-species comparsions of carcinogenicity. British Journal of Cancer 1980; 41: 454-468.
• Linnet K. A review on the methodology for assessing diagnostic tests. Clinical Chemistry 1988; 34: 1379-1386.
• Grimes DA, Schulz KF. Uses and abuses of screening tests. The Lancet 2002; 359: 881-884.
• Altman DG, Bland JM. Diagnostic tests 2: Predictive values. British Medical Journal 1994; 309: 102.
• Smith RD. Decision analysis in the evaluation of diagnostic tests. Journal of the American Veterinary Medical Association 1993; 203: 1184-1192.
• Lilford RJ, Pauker SG, Braunholtz DA, Chard J. Getting research findings into practice: Decision analysis and the implementation of research findings. British Medical Journal 1998; 317: 405-409.
• Smith RD, Slenning BD. Decision analysis: dealing with uncertainty in diagnostic testing. Preventive Veterinary Medicine 2000; 45: 139-162.
• Marshall R. The predictive value of simple rules for combining two diagnostic tests. Biometrics 1989; 45: 1213-1222.

Need for EBT

• Pound P, Ebrahim S, Sandercock P, Bracken MB, Roberts I, Reviewing Animal Trials Systematically (RATS) Group. Where is the evidence that animal research benefits humans? British Medical Journal 2004; 328: 514-517.
• Gori GB. The costly illusion of regulating unknowable risks. Regulatory Toxicology and Pharmacology 2001; 34: 205-212.
• Golden R, Doul J, Waddell W, Mandel J. Potential human cancer risks from exposure to PCBs: a tale of two evaluations. Critical Reviews in Toxicology 2003; 33: 543-580.
• Rudén C. The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments. Regulatory Toxicology and Pharmacology 2001; 34: 3-16.
• Rudén C. Interpretations of primary carcinogenicity data in 29 trichloroethylene risk assessments. Toxicology 2001; 169: 209-225.
• Rudén C. The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments. The trichloroethylene example. Regulatory Toxicology and Pharmacology 2002; 80-94.
• Weed DL. Weight of evidence: A review of concepts and methods. Risk Analysis 2005; 1545-1557.
• Kirkland DJ, Aardema M, Henderson L, Mueller L (2005). Evaluation of the ability of a battery of three in vitro and non-carcinogens: I. Sensitivity, specificity and relative predictivity. Mutat Res 584: 1-256.
• Balls, M., Amcoff, P., Bremer, S., Casati, S., Coecke, S., Combes, R., Corvi, R., Curren, R., Eskes, C., Fentem, J., Gribaldo, L., Halder, M., Hartung, T., Hoffmann, S., Schechtman, L., Scott, L., Spielmann, H., Tice, R., Wagner, D., Zuang, V. (2006). The principles of weight of evidence validation of test methods and strategies. The report and recommendations of ECVAM Workshop 58. Alternatives to Laboratory Animals 34: 603-20.