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…

CertaraNovember 10, 2025

Webinar

In silico Safety and Toxicology assessment: ToxStudio®

CertaraOctober 30, 2025

Video

Ask the Experts: All About Safety Documents

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

CertaraOctober 7, 2025

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.…

CertaraOctober 3, 2025

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…

CertaraOctober 2, 2025

Conference

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

CertaraSeptember 22, 2025

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…

CertaraSeptember 22, 2025

Announcement

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

RADNOR, Pa. – September 17, 2025 – Certara, Inc. (Nasdaq: CERT), a global leader in…

CertaraSeptember 17, 2025

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…

CertaraSeptember 5, 2025

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.

CertaraAugust 19, 2025

Drug Safety