Drug Safety Archives

Fact Sheet

Add Off-target Risk Profiling to Your Analyses

Certara's cheminformatics solution, D360, supports a key feature of Secondary Intelligence: a low-medium-high ranking of…

CertaraJanuary 5, 2026

Publication

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

This study synthesizes data from a large body of clinical trials to evaluate rates of…

CertaraDecember 18, 2025

Case Study

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…

CertaraDecember 12, 2025

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

On-Demand Webinar

In silico Safety and Toxicology assessment: ToxStudio®

Discover how Certara’s ToxStudio align with FDA’s roadmap to reduce animal testing and transform preclinical…

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

Drug Safety

Add Off-target Risk Profiling to Your Analyses

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

In silico Safety and Toxicology assessment: ToxStudio®

Ask the Experts: All About Safety Documents

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

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

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

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

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