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Abstract:
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Current risk assessment approaches rely heavily on experiments with inbred rodent strains to derive dose response relationships. Though the homogeneous genetic background provides advantages in certainly respects, the ad hoc nature in accounting for biological diversity in assessing risk for human health is a notable weakness. Induced pluripotent stem cell (iPSC) technology provides exciting opportunities for measuring and modeling toxicological response of different cell types from human subjects of diverse background. It also enables the collection of data on complex toxicity response profiles such as functional response data. Due to the incorporation of diverse human subjects and the functional form, new statistical methods will be required for the modeling of toxicity and risk assessment. Developments in Bayesian models and functional data analysis are especially promising. This in turn leads to multiple possibilities to expand current methodology to obtain a more complete picture of human toxicity response. In this presentation, recent work on statistical approaches and further challenges will be discussed using cardiotoxicity for an important cancer drug as an example.
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