ToxSci Advance Access published online on September 21, 2009
Toxicological Sciences, doi:10.1093/toxsci/kfp217
Approaches for Assessing Risks to Sensitive Populations: Lessons Learned from Evaluating Risks in the Pediatric Population
* Medical College of Wisconsin, Milwaukee, WI, USA 53226-4801, rhines{at}mcw.edu
Bayer CropScience, Research Triangle Park, NC, USA 27709, dana.sargent{at}bayercropscience.com
University of Aarhus, DK-8000 Åarhus C, Denmark, ha{at}mil.au.dk
NIH National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA 27709, birnbaumls{at}niehs.nih.gov, portier{at}niehs.nih.gov
¶ Alfred I. duPont Hospital for Children, Wilmington, DE, USA 19899, rbrent{at}nemours.org
|| ILSI Health and Environmental Sciences Institute, Washington, DC, USA 20005, ndoerrer{at}hesiglobal.org
US Environmental Protection Agency, Research Triangle Park, NC 27709, hubal.elaine{at}epa.gov, luebke.robert{at}epamail.epa.gov
Dow AgroSciences, Indianapolis, IN, USA 46268, drjuberg{at}dow.com
# (formerly with the European Food Safety Authority, I-43100 Parma, Italy), christianlaurent{at}alice.it
** Federal Institute for Drugs and Medical Devices, BfArM, D-53175 Bonn, Germany, k.olejniczak{at}bfarm.de
US Food and Drug Administration National Center for Toxicological Research, Jefferson, AR, USA 72079, william.slikker{at}fda.hhs.gov
1 Address correspondence to Nancy G. Doerrer, ILSI Health and Environmental Sciences Institute, 1156 Fifteenth St., NW, Second Floor, Washington, DC 20005. 202-659-3306 (phone), 202-659-3617 (fax); ndoerrer{at}hesiglobal.org (e-mail).
Received July 5, 2009; revision received September 4, 2009; accepted September 8, 2009
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Abstract |
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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 HESI 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 manuscript 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 also are made.
Key Words: sensitive populations; pharmacokinetics; pharmacodynamics; genetic variability; pediatric population; risk assessment; exposure assessment.