Drug Safety Archives

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

Webinar

In silico Safety and Toxicology assessment: ToxStudio®

Certara2025 年 10 月 30 日

视频

Ask the Experts: All About Safety Documents

Get clear, practical answers to the top 5 safety reporting questions & learn how to…

Certara2025 年 10 月 7 日

White Paper

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

Replace or waive TQT studies with validated C-QT analysis strategies accepted by FDA, EMA, PMDA.…

Certara2025 年 10 月 3 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

Announcement

Certara Launches DIDB® Concomitant Meds Navigator, Extending Leadership in Drug Interaction Science

Meet DIDB Concomitant Meds Navigator—an evidence-based tool to identify contraindicated or monitored co-medications and manage…

Certara2025 年 9 月 22 日

Announcement

Certara Launches Libra™: AI-Powered Drug-Induced Liver Injury Prediction Tool

RADNOR, Pa. – 2025 年 9 月 17 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in…

Certara2025 年 9 月 17 日

Blog

Clinical Trials Regulation (EU) No. 536/2014 – The Impact on Annual Safety Reporting

Stay compliant with EU rules for the pharmaceutical industry. Learn about annual safety reports and…

Certara2025 年 9 月 5 日

On-Demand Webinar

ToxStudio®: In silico tools to accelerate toxicology assessments

Watch to explore ToxStudio—in silico toxicology platform designed to address key preclinical safety challenges.

Certara2025 年 8 月 19 日

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