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Critical issues in benchmark calculations from continuous data.

Kenny Crump1

  • 1Environ Corporation, Ruston, LA 71270, USA. kcrump@environcorp.com

Critical Reviews in Toxicology
|June 20, 2002
PubMed
Summary

The benchmark dose (BMD) calculation from continuous data is complex. This study examines the hybrid approach for comparable BMD estimates and suggests methods for model and risk level selection in dose-response analysis.

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Area of Science:

  • Toxicology
  • Risk Assessment
  • Biostatistics

Background:

  • The benchmark dose (BMD) is increasingly used by regulatory agencies for exposure limits, replacing the NOAEL.
  • Calculating BMD from continuous response data presents challenges, lacking clear consensus on methodology.
  • Key issues include defining BMD from continuous data for comparability with binary data and selecting appropriate dose-response models and risk levels.

Purpose of the Study:

  • To examine the hybrid approach for calculating BMD from continuous data, ensuring comparability with binary data.
  • To explore the impact of converting continuous data to binary form on BMD estimates.
  • To investigate model uncertainty and the effect of control data in BMD calculations, particularly for epidemiological data.

Main Methods:

  • Utilized the "hybrid" approach (Gaylor and Slikker, 1990; Crump, 1995) to express BMD from continuous data comparably to binary data.
  • Quantified the effect of converting continuous data to binary form on BMD.
  • Explored model uncertainty and the influence of control data on BMD estimates, focusing on linear or convex mean response models.

Main Results:

  • The hybrid approach provides a framework for comparable BMD estimates from continuous and binary data.
  • Model uncertainty can be managed by restricting the class of allowable dose-response models.
  • Control data have a limited effect on BMD when linear or convex models are used for the mean response, which are biologically plausible at low doses.

Conclusions:

  • The hybrid approach offers a viable method for calculating BMD from continuous data, facilitating regulatory risk assessment.
  • Selecting appropriate dose-response models and risk levels is crucial for robust BMD estimation.
  • Recommendations are provided for model selection and determining the level of additional risk for BMD calculations in toxicological and epidemiological studies.

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