Hierarchical modelling approach for risk assessment in developmental toxicity studies

Abstract

Within the past decade, there has been an increasing interest in the problem of joint analysis of clustered multiple outcome data, motivated by developmental toxicity applications (Fitzmaurice and Laird 1995, Gueorguieva and Agresti 2001, Molenberghs and Ryan 1999, Regan and Catalano 1999, Aerts et al. 2002). So far however, one has tackled the challenges in this setting only partly each time making different restricting assumptions (e.g. restriction to viable fetuses only). Ideally, a model should take the complete correlated hierarchical structure of the data into account. A hierarchical bayesian method will be discussed in this context. Once a suitable model is selected, it can serve as basis for quantitative risk assessment.