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Design of Developmental Toxicity Studies for Assessing Joint Effects of Dose and Duration

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  • Daniel O. Scharfstein
  • Paige L. Williams

Abstract

In the assessment of developmental and reproductive effects, the timing and duration of exposures to chemical compounds or other environmental contaminants are of particular interest, as the gestational cycle is known to have periods of increased sensitivity. The goal of this research is to identify optimal experimental designs for conducting developmental toxicity studies when the effects of both exposure level and duration of exposure are of interest. The elements of the study design considered in this evaluation are the allocation of animals to dose‐duration exposure groups and the determination of the most efficient intermediate exposure levels. The optimality of various designs is assessed via the accuracy of the estimated excess risk as well as testing criteria. Simulation studies are conducted to compare these criteria and determine optimal design strategies under various underlying dose‐response patterns. Asymptotic results are also derived to lend support to the simulation studies.

Suggested Citation

  • Daniel O. Scharfstein & Paige L. Williams, 1994. "Design of Developmental Toxicity Studies for Assessing Joint Effects of Dose and Duration," Risk Analysis, John Wiley & Sons, vol. 14(6), pages 1057-1071, December.
    • Handle: RePEc:wly:riskan:v:14:y:1994:i:6:p:1057-1071
    DOI: 10.1111/j.1539-6924.1994.tb00076.x
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    References listed on IDEAS

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    1. Carole A. Kimmel & David W. Gaylor, 1988. "Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology," Risk Analysis, John Wiley & Sons, vol. 8(1), pages 15-20, March.
    2. Louise Ryan, 1992. "The Use of Generalized Estimating Equations for Risk Assessment in Developmental Toxicity," Risk Analysis, John Wiley & Sons, vol. 12(3), pages 439-447, September.
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