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Considerations in the design of toxicokinetic programs

M N Cayen1

  • 1Department of Drug Metabolism and Pharmacokinetics, Schering-Plough Research Institute, Kenilworth, New Jersey 07033-0539, USA.

Toxicologic Pathology
|March 1, 1995
PubMed
Summary

Toxicokinetic (TK) studies assess systemic drug exposure in toxicity species to link dose levels with toxicological findings. Effective TK programs require early assay development, regulatory compliance, and interdisciplinary collaboration for accurate exposure assessment.

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Area of Science:

  • Pharmacology
  • Drug Development
  • Toxicology

Background:

  • Toxicokinetic (TK) studies are crucial for evaluating systemic exposure to drugs and metabolites in toxicity testing.
  • These studies aim to correlate drug exposure with observed toxicological effects and dose levels.
  • Assessing exposure is vital for predicting potential target organ toxicity.

Purpose of the Study:

  • To outline the objectives and essential components of planning a robust toxicokinetic program.
  • To describe the different types of TK studies (prospective, concomitant, retrospective) and their specific goals.
  • To highlight key considerations in designing and implementing TK programs throughout drug development.

Main Methods:

  • Development of validated plasma assays for drug and metabolite quantification.

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  • Ensuring adherence to Good Laboratory Practices (GLP) for study integrity.
  • Evaluating systemic exposure, often expressed as the area under the plasma concentration-time curve (AUC), considering unbound drug fractions for highly protein-bound compounds.

    • Main Results:

    • TK programs are implemented across various drug development stages, from discovery to chronic toxicity support.
    • Exposure assessment is critical for relating dose to toxicological outcomes.
    • Standardized objectives exist, but TK program design varies among organizations.

    Conclusions:

    • Effective TK programs necessitate early planning, appropriate assay development, and adherence to regulatory guidelines.
    • Interdisciplinary collaboration among toxicologists, kineticists, and other experts is essential for successful TK study design and execution.
    • Variability in TK program design is influenced by drug properties, species, formulation, and available resources.