Animal to human PK translation

Case Study

Everything related to Modeling & Simulation and Data Analytics
We make it possible!

Animal to human PK translation

Goal: Support selection of First-in-Human dose

Available data

  • Plasma concentration measurements in mice, rat, and dog (>10 studies)
  • IV and oral administration
  • Efficacy and tox study data in animals allowing to assume potential concentration thresholds for efficacy and safety


  • Potential non-linearities observed in animal
  • What might be the source?
  • Could it translate to human?
  • Is the currently planned starting dose realistic?
  • Are the dose strengths currently planned to be manufactured reasonable?


  • Integration of all available data
  • Weight-based allometric scaling to human
  • Simulation based assessment of candidate dose scenarios in human

Benefit for the Client

  • Refined assumption on likely human PK
  • More informed dose selection
  • Buy-in of stakeholders (incl. investors)
  • Improved FIH study design (e.g. PK sampling times, follow-up time)

R based PK/PD modeling workflow

We helped a client leverage the power of open-source modeling tools for internal modeling and simulation tasks

Reproducible Analyses

Computation without Borders and Reproducible Analyses: IQ Desktop

Phase IIb Design

Confident transition to full development