A framework for fit-for-purpose dose response assessment

Regulatory Toxicology and Pharmacology

Volumn 66, Issue 2, 2013, Pages 234-240

  Bette Meek, M E ^a   Bolger, Michael ^b,j   Bus, James S ^c,k   Christopher, John ^d   Conolly, Rory B ^e   Lewis, R Jeffrey ^f   Paolini, Gregory M ^g   Schoeny, Rita ^e   Haber, Lynne T ^h   Rosenstein, Amy B ⁱ   Dourson, Michael L ^h  

^a UNIVERSITY OF OTTAWA   (Canada)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c DOW CHEMICAL COMPANY   (United States)

^d Research Triangle Park ^*  (United States)

^e U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^f EXXONMOBIL UPSTREAM RESEARCH COMPANY   (United States)

^g RISK SCIENCES INTERNATIONAL   (Canada)

^h Toxicology Excellence for Risk Assessment   (United States)

ⁱ Independent Consultant   (United States)

^j Center for Chemical Regulation and Food Safety Exponent   (United States)

^k Center for Toxicology and Mechanistic Biology Exponent   (United States)

more..

Author keywords

Endogenous; Fit for purpose; Framework; Methods compendium; Mode of action; Problem formulation; Tier

Indexed keywords

CHLORPYRIFOS; CHOLINESTERASE;

ANALYTIC METHOD; ARTICLE; CONCEPTUAL FRAMEWORK; DECISION MAKING; DOSE RESPONSE; ENVIRONMENTAL PROTECTION; FIT FOR PURPOSE DOSE RESPONSE ASSESSMENT; METHODOLOGY; PHARMACODYNAMICS; POPULATION DYNAMICS; PRIORITY JOURNAL; PROCESS OPTIMIZATION; RISK MANAGEMENT; WORKSHOP;

EID: 84877828538     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.03.012     Document Type: Article

References (22)

1. Carmichael N., Bausen M., et al. Using mode of action information to improve regulatory decision-making: an ECETOC/ILSI RF/HESI workshop overview. Crit. Rev. Toxicol. 2011, 41:175-186.
2. Crump K.S., Hoel D.G., et al. Fundamental carcinogenic processes and their implications for low dose risk assessment. Cancer. Res. 1976, 36:2973-2979.
3. Grant R.L., Kadlubar B.J., et al. Evaluation of acute inhalation toxicity for chemicals with limited toxicity information. Regul. Toxicol. Pharmacol. 2007, 47:261-273.
4. Hattis D., Lynch M.K. Empirically observed distributions of pharmacokinetic and pharmacodynamic variability in humans-implications for the derivation of single point component uncertainty factors providing equivalent protection as existing RfDs. Toxicokinetics in Risk Assessment 2007, 69-93. Informa Healthcare USA, Inc. J.C. Lipscomb, E.V. Ohanian (Eds.).
5. Hattis D., Baird S., Goble R. A straw man proposal for a quantitative definition of the RfD. Drug Chem. Toxicol. 2002, 25:403-436.
6. Hinderliter P.M., Price P.S., et al. Development of a source-to-outcome model for dietary exposures to insecticide residues: an example using chlorpyrifos. Regul. Toxicol. Pharmacol. 2011, 61:82-92.
7. IPCS (International Programme on Chemical Safety), 2005. Chemical-specific adjustment factors for interspecies differences and human variability: guidance document for use of data in dose/concentration-response assessment. Available at http://whqlibdoc.who.int/publications/2005/9241546786_eng.pdf.
8. IPCS (International Programme on Chemical Safety), 2006. IPCS framework for analysing the relevance of a cancer mode of action for humans and case studies. Available at http://www.who.int/ipcs/methods/harmonization/areas/cancer_mode.pdf.
9. IPCS (International Programme on Chemical Safety) Assessment of Combined Exposures to Multiple Chemicals: Report of a WHO/IPCS International Workshop on Aggregate/Cumulative Risk Assessment 2007, World Health Organization, Geneva, Switzerland.
10. Kirman C.R., Grant R.L. Quantitative human health risk assessment for 1,3-butadiene based upon ovarian effects in rodents. Regul. Toxicol. Pharmacol. 2012, 62:371-384.
11. Lee J.W., Devanarayan V., et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 2006, 23:312-328.
12. Meek M.E., Armstrong V.C. The assessment and management of industrial chemicals in Canada. Risk Assessment of Chemicals 2007, 591-615. Kluwer Academic Publishers. K. Van Leeuwen, T. Vermeire (Eds.).
13. Meek M.E., Boobis A.R., et al. Risk assessment of combined exposure to multiple chemicals: a WHO/IPCS framework. Regul. Toxicol. Pharmacol. 2011, 60:S1-S14.
14. NRC (National Research Council) Risk Assessment in the Federal Government: Managing the Process 1983, National Academy Press, Washington, DC.
15. NRC (National Research Council) Toxicity Testing in the 21st Century: A vision and a Strategy 2007, National Academy Press, Washington, DC.
16. NRC (National Research Council), 2009. Science and Decisions: Advancing Risk Assessment (NAS Final Report). Available at http://www.nap.edu/catalog.php?record_id=12209.
17. Price P.S., Schnelle K.D., et al. Application of a source-to-outcome model for the assessment of health impacts from dietary exposures to insecticide residues. Regul. Toxicol. Pharmacol. 2011, 61:23-31.
18. Swenberg J.A., Lu K., et al. Endogenous versus exogenous DNA adducts: their role in carcinogenesis, epidemiology, and risk assessment. Toxicol. Sci. 2011, 120:S130-145.
19. TCEQ (Texas Commission on Environmental Quality), 2012. TCEQ Guidelines to Develop Toxicity Factors (proposed). Chief Engineer's Office. RG-442 (revised).
20. U.S.Epa (United States Environmental Protection Agency) Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry 1994, US Environmental Protection Agency, Washington, DC, EPA/600/8-90/066F.
21. U.S. EPA (United States Environmental Protection Agency), 2011. Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation (external review draft); EPA/100/J-11/001. Available at: http://www.epa.gov/raf/DDEF/index.htm.
22. Yokota F., Thompson K.M. Value of information analysis in environmental health risk management decisions: past, present and future. Risk Anal. 2004, 24:635-650.