3.2 Quantification of uncertainty within and between species and the role of uncertainty factors

1 Barton HA  Chiu WA  Setzer RW  Andersen ME  Bailer AJ  Bois FY  . Characterizing uncertainty and variability in physiologically based pharmacokinetic models: state of the science and needs for research and implementation. Toxicol Sci 2007; 99: 395–402.

2 Renwick AG  Barlow SM  Hertz-Piccioto I  Boobis AR  Dybing E  Edler L  . Risk characterization of chemicals in food and diet. Final part of Food Safety in Europe (FOSIE): risk assessment of chemicals in food and diet (EC concerted action QLK1-1999-00156). Food Chem Toxicol 2003; 41: 1211–1271.

3 Edler L  . Uncertainty in biomonitoring and kinetic modelling. Ann NY Acad Sci 1999; 895: 80–100.

4 Lehman AJ  Fitzhugh OG  . Quaterly report to the editor on topics of current interest-100-fold margin of safety. Assoc Food Drug Off US Q Bull 1954; 18: 33–35.

5 Renwick AG  Lazarus NR  . Human variability and noncancer risk assessment – an analysis of the default uncertainty factor. Regul Toxicol Pharmacol 1998; 27: 3–20.

6 World Health Organization . Chemical specific adjustment factors for interspecies differences and human variability. Guidance document for use of data in dose/concentration – response assessment. Geneva: WHO; 2005.

7 Dorne JCLM  Renwick AG  . The refinement of uncertainty/safety factors in risk assessment by the incorporation of data on toxicokinetic variability in humans. Toxicol Sci 2005; 86: 20–26.

9 Chen JJ  Moon H  Kodell RL  . A probabilistic frame work for non-cancer risk assessment model. Regul Toxicol Pharmacol 2007; 48: 45–50.

10 Kodell RL  Chen JJ  . On the use of hierarchical probabilistic models for characterizing and man aging uncertainty in risk/safety assessment. Risk Anal 2007; 27: 433–437.