1. Overview of approach to noncancer risk assessment / Lynne Haber -- 2. Guidance for the development of chemical-specific adjustment factors : integration with mode of action frameworks / Bette Meek and Andrew Renwick -- 3. Derivation and modeling of mechanistic data for use in risk assessment / Ronald L. Melnick -- 4. 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 reference doses / Dale Hattis and Meghan Keaney Lynch -- 5. Use of classical pharmacokinetic evaluations in drug development and safety assessment / Rakesh Dixit and Peter Ward -- 6. Considerations for applying physiologically based pharmacokinetic models in risk assessment / Chadwick Thompson, Babasaheb Sonawane, Andy Nong, and Kannan Krishnan -- 7. Considerations of design and data when developing physiologically based pharmacokinetic models / Peter J. Robinson, Jeffery M. Gearhart, Deirdre A. Mahle, Elaine A. Merrill, Teresa R. Sterner, Kyung O. Yu, and John C. Lipscomb -- 8. In silico predictions of partition coefficients for physiologically based pharmacokinetic models / Kannan Krishnan, Andy Nong, and Sami Haddad -- 9. In vitro to in vivo extrapolation of metabolic rate constants for physiologically based pharmacokinetic models / Gregory L. Kedderis -- 10. Use of physiologically based pharmacokinetic modeling to evaluate implications of human variability / P. Robinan Gentry and Harvey J. Clewell III -- 11. Developmental aspects of children's pharmacokinetics / Gary Ginsberg, Dale Hattis, and Babasaheb Sonawane -- 12. Sensitive populations and risk assessment / Michael Dourson and Daniel Drinan -- 13. Statistical issues in physiologically based pharmacokinetic modeling / Weihsueh A. Chiu -- 14. Drug development and the use of pharmacokinetics/toxicokinetics in selecting the first dose of systemically administered drugs in humans : a nonclinical perspective / Abigail Jacobs -- 15. Pharmacokinetic/physiologically based pharmacokinetic models in integrated risk information system assessments / Robert S. DeWoskin, John C. Lipscomb, Chadwick Thompson, Weihsueh A. Chiu, Paul Schlosser, Carolyn Smallwood, Jeff Swartout, Linda Teuschler, and Allan Marcus.