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Human Clinical Exposure Studies: Body Box or Pandora’s Box?

  • Conference paper
Inhalation Toxicology

Part of the book series: ILSI Monographs ((ILSI MONOGRAPHS))

Abstract

The development of air quality standards or assignment of risk for acute and/or chronic inhalation of low-level environmental air pollutants is complex. Typically, the database for these exercises arises from three separate arenas: the epidemiologic study, animal exposures, and human inhalation studies. Each possesses unique advantages but also carries significant limitations. For example, the epidemiologic study examines the “real world” but then struggles with real-world problems: such important confounders as cigarette smoking, socioeconomic status, and occupational factors, as well as the difficulties in characterizing exposure. This is contrasted with inhalation studies in animals which allow remarkable precision in quantifying exposure duration and concentration, a wide variety of physiological, biochemical, and histological endpoints, and the opportunity to examine extremes of the exposure-response relationship. Often, however, consideration of these studies in the standard-setting process is constrained by difficulty in extrapolating from animals to humans, and occasionally exclusion results from unrealistic exposure design.

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Author information

Authors and Affiliations

  1. University of Rochester, Rochester, NY, 14642, USA

    M. J. Utell

Authors
  1. M. J. Utell
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Editor information

Editors and Affiliations

  1. Department of Veterinary Pathology, University of California, Davis, CA, 95616, USA

    Donald L. Dungworth Ph.D. M.R.C.V.S

  2. Bayer AG, Institute for Toxicology, 5600, Wuppertal-Elberfeld, Germany

    Georg Kimmerle Dr.med.

  3. Abbott Laboratories, Abbott Park, IL, 60064, USA

    James Lewkowski M.D.

  4. Inhalation Toxicology Research Institute, Lovelace Biomedical and Environmental Research Institute, P.O. Box 5890, Albuquerque, NM, 87185, USA

    Roger O. McClellan D.V.M.

  5. Fraunhofer Institute of Toxicology and Aerosol Research, Nikolai-Fuchs-Strasse 1, 3000, Hannover 61, Germany

    Werner Stöber Dr.rer.nat.

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© 1988 Springer-Verlag New York Inc.

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Utell, M.J. (1988). Human Clinical Exposure Studies: Body Box or Pandora’s Box?. In: Dungworth, D.L., Kimmerle, G., Lewkowski, J., McClellan, R.O., Stöber, W. (eds) Inhalation Toxicology. ILSI Monographs. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-61355-5_17

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  • DOI: https://doi.org/10.1007/978-3-642-61355-5_17

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-64806-9

  • Online ISBN: 978-3-642-61355-5

  • eBook Packages: Springer Book Archive

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