Journal Article

Approaches for Assessing Risks to Sensitive Populations: Lessons Learned from Evaluating Risks in the Pediatric Population

Ronald N. Hines, Dana Sargent, Herman Autrup, Linda S. Birnbaum, Robert L. Brent, Nancy G. Doerrer, Elaine A. Cohen Hubal, Daland R. Juberg, Christian Laurent, Robert Luebke, Klaus Olejniczak, Christopher J. Portier and William Slikker

in Toxicological Sciences

Volume 113, issue 1, pages 4-26
Published in print January 2010 | ISSN: 1096-6080
Published online September 2009 | e-ISSN: 1096-0929 | DOI: http://dx.doi.org/10.1093/toxsci/kfp217
Approaches for Assessing Risks to Sensitive Populations: Lessons Learned from Evaluating Risks in the Pediatric Population

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Assessing the risk profiles of potentially sensitive populations requires a “tool chest” of methodological approaches to adequately characterize and evaluate these populations. At present, there is an extensive body of literature on methodologies that apply to the evaluation of the pediatric population. The Health and Environmental Sciences Institute Subcommittee on Risk Assessment of Sensitive Populations evaluated key references in the area of pediatric risk to identify a spectrum of methodological approaches. These approaches are considered in this article for their potential to be extrapolated for the identification and assessment of other sensitive populations. Recommendations as to future research needs and/or alternate methodological considerations are also made.

Keywords: sensitive populations; pharmacokinetics; pharmacodynamics; genetic variability; pediatric population; risk assessment; exposure assessment

Journal Article.  16652 words.  Illustrated.

Subjects: Medical Toxicology ; Toxicology (Non-medical)

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