PK / PD Modeling
Quantitative pharmacology from first-in-human trials to approval, encompassing population PK, exposure-response analysis, and DDI assessment under ICH M12.
Model-Informed Drug Development (MIDD)
Quantitative pharmacology supporting every dose decision.
We translate PK/PD data into regulatory dose decisions, aligning our work with current global dose optimization standards and ICH M12.
ACRO supports model-informed approaches in early development, from predicting first-in-human starting doses through dose finding and regulatory dose justification.
Why it matters
Dose selection is an ongoing process from first-in-human trials to approval, with each stage providing evidence for the next. Regulatory expectations for oncology dose justification have also increased.
MTD alone is no longer sufficient; exposure-response evidence across efficacy, safety, and tolerability is expected at approval. ICH M12, which took effect in 2024, establishes a new international framework for drug interaction (DDI) studies.
Modeling connects these requirements with practical decisions, turning PK/PD data into evidence regulators can assess and clinical teams can use directly.
What we offer
Preclinical → First-in-Human
- FIH starting dose prediction — Allometric scaling, MABEL, and PK/PD-based approaches
- Preclinical PK/TK characterization and prediction of human PK
- Phase 1 study design and protocol development
Dose finding
- Noncompartmental analysis (NCA) and PK parameter estimation
- Population PK modeling and exposure-response analysis
- Dose selection consulting — RP2D in oncology, optimal biological dose (OBD), and doses for Phase 2
- PBPK modeling and DDI risk assessment under ICH M12
- Optimal PK sampling design — Sparse and intensive sampling
- PK in special populations — Renal and hepatic impairment and pediatric considerations
Regulatory deliverables
- MFDS pre-IND meeting preparation and MIDD briefing packages
- Clinical pharmacology sections for IBs, CSRs, and submission documents
- Bioequivalence and bridging study support through NCA-based PK comparisons
Related services
- Biostatistics — Modeling results inform dose escalation simulations and the SAP.
- Protocol Development — Sampling schedules and PK assessments are incorporated into the protocol.
- IND Strategy — Modeling supports MIDD meetings and regulatory dose justification.