Biokinetics and Metabolism

Physiologically based pharmacokinetic modeling (PBPK)

  • Custom model development
  • Rapid PBPK (HT-PBPK) for early discovery and prioritization
  • Dose, route, and species extrapolation
  • Early life and other sensitive populations
  • Regulatory submission¬†

In vitro-to-in vivo extrapolation (IVIVE)

  • Quantitative IVIVE of cell-based toxicity assay results
  • High-throughput IVIVE (HT IVIVE) of in vitro screening assays
  • Derivation of Oral Equivalent Dose (OED) and Activity-to-Exposure Ratio (AER) from HT in vitro data

In vitro metabolism studies

  • Intrinsic clearance (Clint)
  • Enzyme kinetic assays for IVIVE and PBPK parameterization

In vitro assay designs and in vitro biokinetics

  • Repeated dosing in vitro in long-term cultures
  • HT and fit-for-purpose metabolism assays in organotypic culture models
  • Biokinetic modeling of in vitro assay systems

Facilitating incorporation of historical in vivo data into human safety assessment using IVIVE and PBPK modeling