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Drinking Water and Health, Volume 8 Pharmacokinetics in Risk Assessment (1987) / Chapter Skim
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Perspectives
Pages 471-476

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From page 471...
... Traditionally, "dose" has been understood to mean the amount of test material administered to a test animal per unit time. As discussed extensively by various speakers in this workshop, the toxic response of an animal is related to exposure through two sets of factors: pharmacok~neticfactors, which govern the concentration in target organs and the interaction of the material with the site of action; and pharmacodynamic factors, which govern the sequence of events that result from the interaction and lead to the manifestation of the toxic response.
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From page 472...
... Unfortunately, in current practice such critical information is often missing from the results of pharmacokinetic studies presented to risk assessors, and the usefulness of pharmacokinetic studies is correspondingly limited to estimation of the bioavailability of the parent material. Problems in applying pharmacokinetics to risk assessment tend to fall into three broad categories: inadequacies of the present data base, incomplete definition or understanding of underlying processes, and inherent uncertainties in the modeling process.
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From page 473...
... Research stimulated by the opportunities and challenges posed by PB-PK assessment, however, could reduce uncertainties associated with the concept of "dose" and thereby allow us to focus on the roles of pharmacodynamic factors, which then may be incorporated into more detailed models. A lack of correlation between the concentration in target tissues and response would be of special interest to toxicologists, because it would disclose major interspecies or intraspecies differences in the pharmacodynamics of the toxicity, which may profoundly affect the validity of risk assessment.
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From page 474...
... Appreciation of the roles of such risk factors is likely to lead to recognition of highly sensitive subpopulations that are not discernible by present testing processes. The workshop brought together a large group of people from diverse backgrounds who share an interest in the application of PB-PK in risk assessment.
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From page 475...
... As was well illustrated by this workshop, PB-PK analysis has genuine promise for improving risk assessment. The basic tools are available.
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Key Terms

  • parent material
  • toxic response
  • toxicologic studies
  • underlying processes
  • dominant factors

  • various speakers
  • mechanistic information
  • pharmacodynamic factors
  • reduce uncertainties
  • bayesian input

  • include differences
  • workshop brought
  • research stimulated
  • sensitivity analysis
  • values estimated

  • scientific credibility
  • challenges posed
  • cause nonlinearity
  • assessment tend
  • participants dealt

  • test animals
  • repair rates
  • pharrnacokinetic modeling
  • especially useful
  • exposure studies

  • effective rate
  • target tissues
  • numerous factors
  • profoundly affect
  • integrate mechanistic


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