ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development
With the release of the draft ICH M15 guidance, MIDD is no longer optional -…
Certara2026年2月18日
Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)
Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…
Certara2026年2月13日
Pediatric Drug Development: From “Wild West” to Model-Informed Confidence
Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…
Certara2026年2月11日
Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions
Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions
Explore how PMx regulatory submissions, exposure-response modeling, and strategic pharmacometrics planning support successful and timely…
Certara2025年12月29日
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…
Certara2025年11月12日
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 Pillsbury2025年11月12日
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…
Certara2025年11月10日
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…
Certara2025年10月24日
Essentials of Model-informed Drug Development in Oncology
Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…
Certara2025年10月6日
