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

On-Demand Webinar

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Watch the on-demand webinar on avoiding drug launch failure. Learn how smarter development, evidence, and…

Certara2025 年 11 月 6 日

Publication

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…

Certara2025 年 10 月 31 日

Case Study

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

Certara2025 年 10 月 2 日

Conference

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

Certara2025 年 9 月 22 日

新闻报导

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

Explore the top challenges in cell & gene therapy commercialization, featuring expert insights from Fran…

Certara2025 年 9 月 12 日

Conference

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

Certara2025 年 9 月 4 日

Case Study

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Find out how Certara helped a small biotech achieve on-time IND and CTA submissions with…

Certara2025 年 8 月 18 日

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治疗领域

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

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

What are the biggest roadblocks still standing in the way of cell and gene therapy commercialization?

The Pharmacometrics Africa Conference 2025 (PMXAC-2025)

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

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