See how model-informed approaches simplify dosing in rare disease programs
Pediatric and rare disease programs rarely allow the dose-ranging that conventional development assumes. Population PK/PD modeling and simulation let sponsors test regimen alternatives in silico, reducing dosing complexity, supporting weight-band simplification, and defending exposure and safety margins with regulators. Certara’s pharmacometrics team applies these methods across every phase, from first-in-human through label-enabling analyses.
