Abstract
This paper develops threshold models for developmental toxicity data. The distinguishing feature of these threshold models is their flexibility in modeling data below threshold with a U-shaped function if the data warrants. The method is applied to actual data from a developmental study which exhibits U-shaped behavior in early dose groups. Results from a simulation study demonstrate the flexibility of the threshold model to pick up on U-shaped trends in the data. In addition, the simulation study reveals important considerations in design of developmental studies.
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