Drug Development Archives | 第 7 页，共 19 页 | 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…

Certara2025 年 11 月 5 日

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.…

Certara2025 年 11 月 3 日

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…

Certara2025 年 10 月 31 日

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…

Certara2025 年 10 月 24 日

On-Demand Webinar

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

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

Certara2025 年 10 月 21 日

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…

Certara2025 年 10 月 15 日

On-Demand Webinar

RAPS 赞助的网络研讨会：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.

Certara2025 年 10 月 9 日

Conference

ICAComP 2025

Certara2025 年 10 月 8 日

Conference

Dutch Medicines Days

Certara2025 年 10 月 7 日

Dizal Pharma

Case Study

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

Certara2025 年 10 月 2 日

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