Supporting KalVista’s NDA Submission for a Novel HAE Treatment
To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…
Danielle Pillsbury2025 年 11 月 12 日
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
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
Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…
Certara2025 年 10 月 31 日
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
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…
Certara2025 年 10 月 2 日
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…
Certara2025 年 9 月 22 日
FAQs on Developing EMA Policy 0070 Submissions
This blog answers audience questions posed during our RAPS webinar, How to Plan for a…
Certara2025 年 9 月 15 日
