Risk Analysis

On the Use of Hierarchical Probabilistic Models for Characterizing and Managing Uncertainty in Risk/Safety Assessment

Journal Article

A general probabilistically‐based approach is proposed for both cancer and noncancer risk/safety assessments. The familiar framework of the original ADI/RfD formulation is used, substituting in the numerator a benchmark dose derived from a hierarchical pharmacokinetic/pharmacodynamic model and in the denominator a unitary uncertainty factor derived from a hierarchical animal/average human/sensitive human model. The empirical probability distributions of the numerator and denominator can be combined to produce an empirical human‐equivalent distribution for an animal‐derived benchmark dose in external‐exposure units.

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