Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs Announcement Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH…Certara2025 年 11 月 12 日
Supporting KalVista’s NDA Submission for a Novel HAE Treatment 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
Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling 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
Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk 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
Build investor confidence with science-backed strategy 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
Certara Reports Third Quarter 2025 Financial Results 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
Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient 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
Web of Evidence: A Practical Guide to Managing Document Dependencies in eCTD Submissions 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
Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation 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
Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights On-Demand Webinar Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…Certara2025 年 11 月 3 日