Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema
Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…
CertaraNovember 12, 2025
Supporting KalVista’s NDA Submission for a Novel HAE Treatment
To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…
Danielle PillsburyNovember 12, 2025
Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling
Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…
CertaraNovember 10, 2025
Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation
This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…
CertaraNovember 5, 2025
Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis
Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…
CertaraOctober 31, 2025
Key Lessons & Opportunities in applying NCA and PopPK to ADCs
Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…
CertaraOctober 24, 2025
