Drug Development Archives | Page 3 of 15 | Certara

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

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

CertaraOctober 31, 2025

Blog

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…

CertaraOctober 24, 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

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

On-Demand Webinar

RAPS Sponsored Webinar: Planning and Preparing Regulatory Submissions Using Top-down Messaging

Access our on-demand webinar and explore proven strategies to develop consistent, high-impact regulatory submission messages.

CertaraOctober 9, 2025

Conference

ICAComP 2025

CertaraOctober 8, 2025

Conference

Dutch Medicines Days

CertaraOctober 7, 2025

Dizal Pharma

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

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