Drug Safety Archives

White Paper

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

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

Certara2025 年 10 月 3 日

Case Study

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

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

Webinar

ToxStudio®: In silico tools to accelerate toxicology assessments

Certara2025 年 8 月 19 日

Publication

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…

Certara2025 年 8 月 13 日

Blog

在药物开发中，用基于模型的浓度-QTc（C-QTc）分析取代传统 TQT 研究，以评估心血管安全性

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

Certara2025 年 8 月 6 日

Webinar

临床试验中降低 DDI 管理风险：介绍 DIDB 联合用药导航工具

Certara2025 年 8 月 5 日

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