Animal to human PK translation
Goal: Support selection of First-in-Human dose
- 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)