Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

Certara2026 年 4 月 7 日

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 -…

Certara2026 年 3 月 18 日

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…

Certara2026 年 2 月 13 日

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…

Certara2026 年 2 月 11 日

Blog

按时交付：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

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…

Certara2025 年 11 月 12 日

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 Pillsbury2025 年 11 月 12 日

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…

Certara2025 年 11 月 10 日

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…

Certara2025 年 10 月 24 日

Blog

肿瘤领域模型引导的药物开发（midd）精要

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

Certara2025 年 10 月 6 日

定量药理学

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

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

按时交付：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

肿瘤领域模型引导的药物开发（midd）精要

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