Journal ArticleDOI
Overview: Using mode of action and life stage information to evaluate the human relevance of animal toxicity data.
Jennifer Seed,Edward W. Carney,Richard A. Corley,Kevin M. Crofton,John M. DeSesso,Paul M. D. Foster,Robert J. Kavlock,Gary L. Kimmel,James E. Klaunig,M. E. Meek,R. Julian Preston,William Slikker,Sonia Tabacova,Gary M. Williams,Jeanette A Wiltse,R. Thomas Zoeller,Penelope A. Fenner-Crisp,Dorothy E. Patton +17 more
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The HRF features a “concordance” analysis of MOA information from both animal and human sources, with a focus on determining the appropriate role for each MOA data set in human risk assessment.Abstract:
A complete mode of action human relevance analysis—as distinct from mode of action (MOA) analysis alone—depends on robust information on the animal MOA, as well as systematic comparison of the animal data with corresponding information from humans. In November 2003, the International Life Sciences Institute's Risk Science Institute (ILSI RSI) published a 2-year study using animal and human MOA information to generate a four-part Human Relevance Framework (HRF) for systematic and transparent analysis of MOA data and information. Based mainly on non-DNA-reactive carcinogens, the HRF features a “concordance” analysis of MOA information from both animal and human sources, with a focus on determining the appropriate role for each MOA data set in human risk assessment. With MOA information increasingly available for risk assessment purposes, this article illustrates the further applicability of the HRF for reproductive, developmental, neurologic, and renal endpoints, as well as cancer. Based on qualitative and ...read more
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Journal ArticleDOI
IPCS framework for analyzing the relevance of a noncancer mode of action for humans.
Alan R. Boobis,John E. Doe,Barbara Heinrich-Hirsch,M. E. Meek,Sharon Munn,Mathuros Ruchirawat,Josef Schlatter,Jennifer Seed,Carolyn Vickers +8 more
TL;DR: This work has now been extended to noncancer effects, with the eventual objective of harmonizing framework approaches to both cancer and noncancer endpoints.
Journal ArticleDOI
The adverse outcome pathway concept: A pragmatic tool in toxicology
TL;DR: These newly postulated AOPs can serve a number of ubiquitous purposes, including the establishment of (quantitative) structure-activity relationships, the development of novel in vitro toxicity screening tests and the elaboration of prioritization strategies.
Journal ArticleDOI
IPCS Framework for Analyzing the Relevance of a Noncancer Mode of Action for Humans
Alan R. Boobis,Samuel M. Cohen,Vicki L. Dellarco,Douglas McGregor,Carolyn Vickers,Deborah Willcocks,William H. Farland +6 more
TL;DR: The IPCS human relevance framework for cancer provides an analytical tool to enable the transparent evaluation of the data, identification of key data gaps, and structured presentation of information that would be of value in the further risk assessment of the compound, even if relevancy cannot be excluded.
Journal ArticleDOI
New developments in the evolution and application of the WHO/IPCS framework on mode of action/species concordance analysis
M. E. Meek,Alan R. Boobis,I. Cote,Vicki L. Dellarco,G. Fotakis,S. Munn,Jennifer Seed,Carolyn Vickers +7 more
TL;DR: The World Health Organization/International Programme on Chemical Safety mode of action/human relevance framework has been updated to reflect the experience acquired in its application and extend its utility to emerging areas in toxicity testing and non‐testing methods.
Journal ArticleDOI
Thyroid disrupting chemicals: mechanisms and mixtures.
TL;DR: Assessing the health risks of thyroid disruption by environmental xenobiotics will need to include an improved understanding of how divergent mechanisms alter THs and consequent adverse impacts on nervous system development.
References
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Journal ArticleDOI
A framework for human relevance analysis of information on carcinogenic modes of action.
M. E. Meek,John R. Bucher,Samuel M. Cohen,Vicki L. Dellarco,Richard N. Hill,Lois D. Lehman-McKeeman,David G. Longfellow,Timothy P. Pastoor,Jennifer Seed,Dorothy E. Patton +9 more
TL;DR: By providing a systematic approach to using MOA data, the HRF offers a new tool for the scientific community's overall effort to enhance the predictive power, reliability and transparency of cancer risk assessment.
Journal ArticleDOI
IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis.
C. Sonich-Mullin,R. Fielder,J. Wiltse,Karl Baetcke,J. Dempsey,Penelope A. Fenner-Crisp,D. Grant,M. Hartley,A. Knaap,D. Kroese,Inge Mangelsdorf,E. Meek,J.M. Rice,Maged Younes +13 more
TL;DR: A conceptual framework was developed, based on the general principles involved in considering the chemical induction of a specific tumor in animals, based partly on the Bradford Hill criteria for causality as modified by Faustman et al. (1997) for developmental toxicity.
Journal ArticleDOI
Evaluating the human relevance of chemically induced animal tumors.
Samuel M. Cohen,James E. Klaunig,M. Elizabeth Meek,Richard N. Hill,Timothy P. Pastoor,Lois D. Lehman-McKeeman,John R. Bucher,David G. Longfellow,Jennifer Seed,Vicki L. Dellarco,Penelope A. Fenner-Crisp,Dorothy E. Patton +11 more
TL;DR: This FORUM paper features a systematic analysis for using mode of action information from animal and human studies, based in part on case examples involving environmental chemicals and pharmaceuticals.
Journal ArticleDOI
Science and Judgement in Risk Assessment
TL;DR: The author examines the reasons for lack of accurate data about the prevalence of food allergy and concludes that well controlled population based prospective studies are required to shed light about problems related to food allergy.