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This study introduces PopGen, a tool for virtual human populations to replace animal testing in risk assessment. PopGen aids in quantitative in vitro-to-in vivo extrapolation (QIVIVE) for chemical and drug safety evaluations.

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Area of Science:

  • Toxicology and Pharmacology
  • Computational Biology and Bioinformatics
  • Environmental Health Sciences

Background:

  • The field of chemical and drug risk assessment is shifting from animal testing to in vitro methods.
  • High-throughput, mechanistic in vitro systems require robust data integration for accurate extrapolation.
  • Quantitative in vitro-to-in vivo extrapolation (QIVIVE) is crucial for translating in vitro findings to human health outcomes.

Purpose of the Study:

  • To introduce PopGen, a user-friendly, open-access web application for generating virtual human populations.
  • To demonstrate PopGen's utility in providing input for physiologically based pharmacokinetic (PBPK) models for QIVIVE.
  • To facilitate the prediction of human population variability in anatomy, physiology, and metabolism.

Main Methods:

  • Development of PopGen, a virtual human population generator with a web-based interface.
  • Integration of PopGen with Physiologically Based Pharmacokinetic (PBPK) models.
  • Utilizing PopGen outputs for exposure reconstruction from human biomonitoring data.

Main Results:

  • PopGen provides realistic anatomical, physiological, and metabolic variation for diverse human populations.
  • The application successfully generates input data for PBPK models, enabling QIVIVE.
  • Demonstrated analogy between exposure reconstruction from biomonitoring data and in vitro concentration-response data.

Conclusions:

  • PopGen is a valuable tool for QIVIVE, supporting the move away from animal testing in risk assessment.
  • PBPK models, informed by PopGen, are essential for translating in vitro data to human exposure scenarios.
  • The framework supports integrating data from in vitro, in silico, and in chemico systems for comprehensive risk evaluation.