PK / PD Modeling
Model-Informed Drug Development
Quantitative pharmacology that defends every dose decision.
Translating PK and PD data into regulatory dose decisions — aligned with current global dose-optimization and ICH M12 expectations.
ACRO supports sponsors through model-informed approaches in early development — from first-in-human starting dose projection through dose finding and regulatory dose justification.
Related reading
Why it matters
The dose decision is no longer a single moment. It's a thread that runs from first-in-human through registration — and every step needs to defend the next. Regulatory expectations for oncology dose justification have shifted: MTD alone no longer suffices, and exposure–response evidence across efficacy, safety, and tolerability is expected at registration. ICH M12, effective 2024, sets new global standards for drug–drug interaction studies.
Modeling is what connects these requirements to actual sponsor decisions — turning PK and PD data into a defensible story regulators accept and clinical teams can act on.
What we offer
Preclinical → First-in-Human
- FIH starting dose projection — allometric scaling, MABEL, and PK/PD-guided approaches
- Preclinical PK/TK characterization and human PK prediction
- Phase 1 study design and protocol development
Dose finding
- Non-compartmental analysis (NCA) and PK parameter estimation
- Population PK modeling and exposure–response analysis
- Dose selection advisory — RP2D (oncology), optimal biological dose, or Phase 2 go-forward dose
- PBPK modeling and drug–drug interaction risk assessment, aligned with ICH M12
- Optimal PK sampling design — sparse and intensive
- Special population PK — renal/hepatic impairment, pediatric considerations
Regulatory deliverables
- MFDS pre-IND meeting preparation and MIDD briefing packages
- Clinical pharmacology sections for IB, CSR, and submission dossiers
- Bioequivalence and bridging study support (NCA-based PK comparison)
Related services
- Biostatistics — modeling outputs feed dose-escalation simulation and SAP
- Protocol Development — sampling schedule and PK assessments built into protocol
- IND Strategy — modeling supports MIDD meetings and regulatory dose justification