Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation 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
Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights On-Demand Webinar 按时交付:借助定量药理学分析洞见,顺利推进监管申报 Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…Certara2025 年 11 月 3 日
Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis 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
Key Lessons & Opportunities in applying NCA and PopPK to ADCs 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
AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success 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
Everything You Need to Know About SDTM Blog 关于 SDTM 您需要了解的一切 Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…Certara2025 年 10 月 16 日
Effective Visualizations Using “vachette” to Assess and Communicate Pharmacometric Model Results 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
RAPS Sponsored Webinar: Planning and Preparing Regulatory Submissions Using Top-down Messaging 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