On the use of hierarchical probabilistic models for characterizing and managing uncertainty in risk/safety assessment

Risk Analysis

Volumn 27, Issue 2, 2007, Pages 433-437

  Kodell, Ralph L ^a,c   Chen, James J ^b  

^a UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^b NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

^c UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

Author keywords

ADI; Bayesian; Empirical distribution; Monte Carlo; RfD; Unitary factor

Indexed keywords

ACCIDENT PREVENTION; DOSIMETRY; MATHEMATICAL MODELS; MONTE CARLO METHODS; PHARMACODYNAMICS; UNCERTAINTY ANALYSIS;

EMPIRICAL DISTRIBUTION; PHARMACODYNAMIC MODEL; UNITARY FACTOR;

RISK ANALYSIS;

BAYESIAN ANALYSIS; CANCER; HEALTH RISK; MONTE CARLO ANALYSIS; RISK ASSESSMENT; UNCERTAINTY ANALYSIS;

CANCER RISK; EMPIRICISM; MATHEMATICAL COMPUTING; MODEL; REVIEW; RISK ASSESSMENT;

ANIMALS; BAYES THEOREM; HAZARDOUS SUBSTANCES; HUMANS; MODELS, STATISTICAL; MONTE CARLO METHOD; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PROBABILITY; RISK; RISK ASSESSMENT; SAFETY; UNCERTAINTY;

ANIMALIA;

EID: 34248649341     PISSN: 02724332     EISSN: 15396924     Source Type: Journal    
DOI: 10.1111/j.1539-6924.2007.00895.x     Document Type: Review

References (17)

1. Barnes, D. G., & Dourson, M. (1988). Reference dose (RfD): Description and use in health risk assessments. Regulatory Toxicology and Pharmacology, 8, 471 486.
2. Chen, J. J., Moon, H., & Kodell, R. L. (2007). A probabilistic framework for non-cancer risk assessment. Regulatory Toxicology and Pharmacology, in press. Available at http://www.sciencedirect.com.
3. Clewell, H. J., & Andersen, M. E. (2002). A consistent approach for the application of pharmacokinetic modeling in cancer and noncancer risk assessment. Environmental and Health Perspectives, 10, 85 93.
4. Crump, K. S. (1984). A new method for determining allowable daily intakes. Fundamental Applied Toxicology, 4, 854 871.
5. Dourson, M. L., Knauf, L. A., & Swartout, J. C. (1992). On reference dose (RfD) and its underlying toxicity data base. Toxicology and Industrial Health, 8, 171 189.
6. EPA (U.S. Environmental Protection Agency) 1992). Draft report: A cross-species scaling factor for carcinogen risk assessment based on equivalence of mg/kg3/4/day. Federal Register, 57 (109 24152.
7. EPA (U.S. Environmental Protection Agency) 2002). A Review of the Reference Dose and Reference Concentration Processes. EPA/630/P-02/002F. Available at http://www.epa.gov/iris/backgr-d.htm.
8. EPA (U.S. Environmental Protection Agency) 2005). Guidelines for Carcinogen Risk Assessment. EPA/630/P-03/001F. Washington, DC : Risk Assessment Forum.
9. Gaylor, D. W., Kodell, R. L., Chen, J. J., & Krewski, D 1999). A unified approach to risk assessment for cancer and noncancer endpoints based on benchmark doses and uncertainty/safety factors. Regulatory Toxicology and Pharmacology, 29, 151 157.
10. IPCS (International Programme on Chemical Safety) 2005). Chemical-Specific Adjustment Factors (CSAFs) for Interspecies Differences and Human Variability: Guidance Document for the Use of Data in Dose/Concentration Response Assessment. Harmonization Project Document No. 2. WHO : Geneva. Available at http://whqlibdoc.who.int/publications/2005/9241546786_eng.pdf.
11. Kodell, R. L., Chen, J. J., Delongchamp, R. R., & Young, J. F 2006). Hierarchical models for probabilistic dose-response assessment. Regulatory Toxicology and Pharmacology, 45, 265 272.
12. Lehman, A. J., & Fitzhugh, O. G. (1954). 100-fold margin of safety. Assoc. Food Drug Officials US, Quarterly Bulletin, 18, 33 35.
13. Mantel, N., & Bryan, W. R. (1961). Safety testing of carcinogenic agents. Journal of the National Cancer Institute, 27, 455 470.
14. NRC (National Research Council) 1983). Risk Assessment in the Federal Government: Managing the Process. Washington, DC : National Academy Press.
15. NRC (National Research Council) 2000). Methods for Developing Spacecraft Water Exposure Guidelines. Washington, DC : National Academy Press.
16. OMB (Office of Management and Budget) 2006). Proposed Risk Assessment Bulletin. Available at http://www.whitehouse.gov/omb/inforeg/ proposed_risk_assessment_bulletin_010906.pdf.
17. SOT (Society of Toxicology) 2005). Probabilistic Risk Assessment (PRA): Bridging Components Along the Exposure-Dose-Response Continuum. Society of Toxicology Contemporary Concepts in Toxicology Workshop. Washington, DC. July 25-27, 2005.