PBPK Models Committee

Mission Statement

The committee aims to address key needs related to physiologically based pharmacokinetic (PBPK) modeling practices and applications that could facilitate use of PBPK models more consistently within the risk assessment context.

Working Groups

  • PBPK Template Development

    This work was focused on the development of a general reporting template derived from a consensus among modelers and risk assessors, which expands on an FDA template and will recommend additional elements necessary for submission of PBPK analyses to public health agencies.

  • PBPK Framework Development

    This group is developing a framework to inform the minimum set of in vivo, in vitro, or in silico absorption, distribution, metabolism, or excretion (ADME) data required for various extrapolation applications; manuscript in preparation.

  • Kinetically Derived Maximum Dose (KMD)

    The purpose of this group is to evaluate and address commonly raised technical and scientific issues related to the use of KMD as an approach to select doses in toxicology testing studies or to interpret dose-response study results. Examples of these issues include the appropriate use of PK data to determine dose non-linearity, the possibility of human exposure levels close to KMD, the determination of KMD from sparse blood or tissue concentration data, the use of in silico models to predict systemic dose and key ADME parameters, and the use of KMD to set the top dose in toxicity studies. This group aims to:

    • Discuss best practices and lessons learned on the following:
      • Defining KMD
      • Selecting the appropriate PK parameter to examine dose proportionality
      • Estimating the onset of nonlinear PK based on measurements or predictions
      • Conducting statistical analyses to determine a KMD
    •  Determining and using a KMD to set the top dose in toxicity studies
    • Discuss if and how KMD can be applied in the context of hazard classification, as well as risk assessment
    • Discuss and identify situations where the use of KMD might be limited or not possible (e.g., acute, high-exposure situations)

HESI Staff

Leadership Team

  • Anna Lowit, PhD

    US Environmental Protection Agency

Committee Publications

Filter

PBPK Model Reporting Template for Chemical Risk Assessment Applications

Physiologically-based pharmacokinetic (PBPK) modeling analysis does not stand on its own for regulatory purposes but is a robust tool to support drug/chemical safety assessment. While the development of PBPK models have grown steadily since their emergence, only a handful of models have been accepted to support regulatory ...

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