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Interspecies Extrapolation of Physiological Pharmacokinetic Parameter Distributions

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  • Karen H. Watanabe
  • Frédéric Y. Bois

Abstract

Three methods (multiplicative, additive, and allometric) were developed to extrapolate physiological model parameter distributions across species, specifically from rats to humans. In the multiplicative approach, the rat model parameters are multiplied by the ratio of the mean values between humans and rats. Additive scaling of the distributions is denned by adding the difference between the average human value and the average rat value to each rat value. Finally, allometric scaling relies on established extrapolation relationships using power functions of body weight. A physiologically‐based pharmacokinetic model was fitted independently to rat and human benzene disposition data. Human model parameters obtained by extrapolation and by fitting were used to predict the total bone marrow exposure to benzene and the quantity of metabolites produced in bone marrow. We found that extrapolations poorly predict the human data relative to the human model. In addition, the prediction performance depends largely on the quantity of interest. The extrapolated models underpredict bone marrow exposure to benzene relative to the human model. Yet, predictions of the quantity of metabolite produced in bone marrow are closer to the human model predictions. These results indicate that the multiplicative and allometric techniques were able to extrapolate the model parameter distributions, but also that rats do not provide a good kinetic model of benzene disposition in humans.

Suggested Citation

  • Karen H. Watanabe & Frédéric Y. Bois, 1996. "Interspecies Extrapolation of Physiological Pharmacokinetic Parameter Distributions," Risk Analysis, John Wiley & Sons, vol. 16(6), pages 741-754, December.
    • Handle: RePEc:wly:riskan:v:16:y:1996:i:6:p:741-754
    DOI: 10.1111/j.1539-6924.1996.tb00825.x
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    References listed on IDEAS

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    1. Karen Watanabe & Frédéric Y. Bois & Lauren Zeise, 1992. "Interspecies Extrapolation: A Reexamination of Acute Toxicity Data," Risk Analysis, John Wiley & Sons, vol. 12(2), pages 301-310, June.
    2. Robert C. Spear & Frédéric Y. Bois & Tracey Woodruff & David Auslander & Jennifer Parker & Steve Selvin, 1991. "Modeling Benzene Pharmacokinetics Across Three Sets of Animal Data: Parametric Sensitivity and Risk Implications," Risk Analysis, John Wiley & Sons, vol. 11(4), pages 641-654, December.
    3. Tracey J. Woodruff & Frédéric Y. Bois & David Auslander & Robert C. Spear, 1992. "Structure and Parameterization of Pharmacokinetic Models: Their Impact on Model Predictions," Risk Analysis, John Wiley & Sons, vol. 12(2), pages 189-201, June.
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    Cited by:

    1. Aki Nakayama & Tomomi Isono & Takuro Kikuchi & Iichiro Ohnishi & Junichiro Igarashi & Minoru Yoneda & Shinsuke Morisawa, 2009. "Benzene Risk Estimation Using Radiation Equivalent Coefficients," Risk Analysis, John Wiley & Sons, vol. 29(3), pages 380-392, March.
    2. Céline Brochot & Frédéric Y. Bois, 2005. "Use of a Chemical Probe to Increase Safety for Human Volunteers in Toxicokinetic Studies," Risk Analysis, John Wiley & Sons, vol. 25(6), pages 1559-1571, December.

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