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

Publication

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Immunogenicity poses a significant challenge in biotherapeutics development due to the formation of anti-drug antibodies…

Danielle Pillsbury2025 年 11 月 7 日

Fact Sheet

Build investor confidence with science-backed strategy

Discover expert insights on biotech funding, startup investment strategies, and securing capital for biotech ventures.…

Certara2025 年 11 月 6 日

Press Release

Certara 第三季度报告2025财务业绩

RADNOR, PA— 2025 年 11 月 6 日-- Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development,…

Certara2025 年 11 月 6 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

White Paper

证据之网：eCTD 提交文件中处理文档相关性的实用指南

探索一种实用的框架，通过文档依赖关系映射来规划、撰写和管理监管申报材料。

Certara2025 年 11 月 6 日

Publication

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…

Certara2025 年 11 月 5 日

On-Demand Webinar

按时交付：借助定量药理学分析洞见，顺利推进监管申报

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

Certara2025 年 11 月 3 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

博客

At Certara, we’re proud to support WBUR, Boston’s NPR.

Certara supports public radio because NPR is aligned with our values and helps us spread…

Certara2025 年 10 月 29 日

Certara 服务

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Build investor confidence with science-backed strategy

Certara 第三季度报告2025财务业绩

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

证据之网：eCTD 提交文件中处理文档相关性的实用指南

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

按时交付：借助定量药理学分析洞见，顺利推进监管申报

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

At Certara, we’re proud to support WBUR, Boston’s NPR.

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