Clinical Pharmacology Archives

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…

CertaraNovember 5, 2025

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.…

CertaraNovember 3, 2025

Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

CertaraOctober 21, 2025

Blog

Streamlining PK/PD Reporting: A Smarter Approach to Generating Tables, Figures and Listings

Discover how TFL Studio accelerates PK/PD reporting. Create audit-ready tables, figures, and listings faster with…

CertaraOctober 16, 2025

Publication

Effective Visualizations Using “vachette” to Assess and Communicate Pharmacometric Model Results

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

CertaraOctober 15, 2025

Live Events

PKUK 2025 Pre-Conference Workshop: Modeling & Simulation Updates – QSP and PK/PD Software

– Scarman, Coventry, UK

CertaraOctober 14, 2025

Blog

Alzheimer’s Disease Clinical Trials and Drug Development: Building a Robust Clinical Pharmacology & Model-Informed Strategy

Rajesh Krishna proposes using an integrated clinical pharmacology & model-informed strategy for Alzheimer's disease clinical…

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

Clinical Pharmacology