title: A framework for fit-for-purpose dose response assessment.
abstract: The NRC report Science and Decisions: Advancing Risk Assessment made several recommendations to improve chemical risk assessment, with a focus on in-depth chronic dose-response assessments conducted by the U.S. Environmental Protection Agency. The recommendations addressed two broad elements: improving technical analysis and utility for decision making. To advance the discussions in the NRC report, in three multi-stakeholder workshops organized by the Alliance for Risk Assessment, available and evolving risk assessment methodologies were considered through the development and application of case studies. A key product was a framework (http://www.allianceforrisk.org/Workshop/Framework/ProblemFormulation.html) to guide risk assessors and managers to various dose-response assessment methods relevant to a range of decision contexts ranging from priority setting to full assessment, as illustrated by case studies. It is designed to facilitate selection of appropriate methodology for a variety of problem formulations and includes a variety of methods with supporting case studies, for areas flagged specifically by the NRC committee for consideration--e.g., susceptible sub-populations, population variability and background. The framewok contributes to organization and communication about methodologies for incorporating increasingly biologically informed and chemical specific knowledge into dose-response analysis, which is considered critical in evolving fit-for-purpose assessment to address relevant problem formulations.
authors.affiliation: R. Samuel McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, One Stewart Street, Suite 309, Ottawa, ON K1N 6N5, Canada. bmeek@uottawa.ca
authors.forename: M E
authors.initials: ME
authors.lastname: Bette Meek
authors.forename: Michael
authors.initials: M
authors.lastname: Bolger
authors.forename: James S
authors.initials: JS
authors.lastname: Bus
authors.forename: John
authors.initials: J
authors.lastname: Christopher
authors.forename: Rory B
authors.initials: RB
authors.lastname: Conolly
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Lewis
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Paolini
authors.forename: Rita
authors.initials: R
authors.lastname: Schoeny
authors.forename: Lynne T
authors.initials: LT
authors.lastname: Haber
authors.forename: Amy B
authors.initials: AB
authors.lastname: Rosenstein
authors.forename: Michael L
authors.initials: ML
authors.lastname: Dourson
mesh_terms: D000818:Animals; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D018570:Risk Assessment / Q000379:methods