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OVERVIEW: USING MODE OF ACTION AND LIFE STAGE INFORMATION TO EVALUATE THE HUMAN RELEVANCE OF ANIMAL TOXICITY DATA.
Citation:
SEED, J., E. CARNEY, R. CORLEY, K. M. CROFTON, J. M. DESESSO, P. FOSTER, R. J. KAVLOCK, G. L. KIMMEL, J. KLAUNIG, M. E. MEEK, J. PRESTON, W. SLIKKER, S. TABACOVA, G. M. WILLIAMS, J. WILTSE, R. T. ZOELLER, P. FENNER-CRISP, AND D. PATTON. OVERVIEW: USING MODE OF ACTION AND LIFE STAGE INFORMATION TO EVALUATE THE HUMAN RELEVANCE OF ANIMAL TOXICITY DATA. CRITICAL REVIEWS IN TOXICOLOGY. CRC Press LLC, Boca Raton, FL, 35:663-672, (2005).
Impact/Purpose:
To summarize a workshop aimed at developing a framework to determine the relevancy of animal modes-of-action for extrapolation to humans
Description:
A manuscript summarizes a workshop aimed at developing a framework to determine the relevancy of animal modes-of-action for extrapolation to humans. 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. With MOA information increasingly available for risk assessment purposes, this paper illustrates the applicability of the Human Relevance Framework for reproductive, developmental, neurologic, and renal endpoints, as well as cancer. Based on qualitative and quantitative MOA considerations, the MOA/human relevance analysis also contributes to identifying data needs and issues essential for the dose-response and exposure assessment steps in the overall risk assessment.