Pharmacometrics Archives

Blog

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 -…

CertaraFebruary 18, 2026

Guide

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…

CertaraFebruary 13, 2026

Blog

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…

CertaraFebruary 11, 2026

Blog

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…

CertaraDecember 29, 2025

Publication

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

Case Study

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

Case Study

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

Blog

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

Blog

Essentials of Model-informed Drug Development in Oncology

Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…

CertaraOctober 6, 2025

Conference

2026 SNMMI Annual Meeting

CertaraMay 9, 2025

Pharmacometrics

ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Pediatric Drug Development: From “Wild West” to Model-Informed Confidence

Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Essentials of Model-informed Drug Development in Oncology

2026 SNMMI Annual Meeting

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