First-in-Human • PBPK • Modeling
Safer FIH decisions,
powered by PBPK Modeling
Starting dose, escalation, DDIs, variability: we turn your data into clear, actionable recommendations.
PBPK for FIH - Our approach
Build a robust FIH strategy thanks to PBPK Modeling
A lean, decision-driven approach: targeted simulations, explicit assumptions, and easy-to-use deliverables.
Dose & escalation
- Define a robust starting dose (assumptions + safety margins).
- SAD/MAD simulations for safer, more efficient dose escalation.
DDI & variability
- Anticipate the impact of inhibitors/inducers (CYP/transporters) on exposure.
- Test “worst-case” scenarios and quantify uncertainty.
Submission-ready report
- Results, figures, and structured assumptions ready for protocol and dossier.
- Align clinical, non-clinical, and regulatory teams around shared key messages.
Case studies
Pharmacokinetic prediction using pre-clinical data to develop a PBPK model for FIH translation
The sponsor requested the development of a complete PBPK model incorporating preclinical data, in order to build a PBPK framework for FIH transposition.
A FIH strategy supported by solid quantitative analyses
Clear, defensible recommendations focused on your next decision.