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Toxicogenomics and the Regulatory Framework
GALLAGHER, K., F. M. GOODSAID, D. J. DIX, S. EULING, M. KRAMER, N. MCCARROLL, J. PRESTON, P. SAYRE, B. SEN, D. WOLF, AND W. H. BENSON. Toxicogenomics and the Regulatory Framework. Chapter 14, Darrell R. Boverhof and B. Bhaskar Gollapudi (ed.), Applications of Toxicogenomics in Safety Evaluation and Risk Assessment. John Wiley & Sons Incorporated, New York, NY, , 293-321, (2011).
Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expected to improve dose-response assessments and the underlying premise for linear versus nonlinear extrapolations. The US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) have seized upon this opportunity to enhance their missions of protecting human health and environmental health by moving in a considered, yet expeditious, manner to position themselves to utilize genomics data in regulatory and risk assessment applications as appropriate. This chapter provides an overview of the initiatives within these two US government agencies to develop frameworks for applying toxicogenomics information in their regulatory and risk assessment activities.
Describe initiatives within the EPA and the Food and Drug Administration to develop frameworks for applying toxicogenomics information in their regulatory and risk assessment activities.
Record Details:Record Type: DOCUMENT (BOOK CHAPTER)
Organization:U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF RESEARCH AND DEVELOPMENT
NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LAB
GULF ECOLOGY DIVISION