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

Toxicological Sciences. 2009;113(1):4-26.

Abstract: 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.

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