Model Informed Drug Development 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

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

Blog

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

QSP modeling holds huge promise, but complexity and scalability limit adoption. We review the challenges…

CertaraOctober 22, 2025

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…

CertaraOctober 21, 2025

Press Release

Certara Scientists are Among the Topmost Cited Biopharma Researchers

Certara celebrates its 200 published papers and 11 scientists ranked in the top 2% of…

CertaraOctober 20, 2025

Video

Certara IQ™: The Future of AI-Enabled Scalable QSP Modeling

Explore how Certara IQ redefines QSP modeling through automation, scalability, and AI assistance for faster,…

CertaraOctober 16, 2025

Video

Immuno-oncology (IO) Simulator in Certara IQ™

Learn how Certara IQ’s IO Simulator models immune-tumor interactions and therapy outcomes to guide immuno-oncology…

CertaraOctober 16, 2025

Video

ADC Modeling and Design with Certara IQ™

Discover how Certara IQ helps optimize antibody-drug conjugate properties through mechanistic modeling and early feasibility…

CertaraOctober 16, 2025

Model Informed Drug Development

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

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

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

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

Certara Scientists are Among the Topmost Cited Biopharma Researchers

Certara IQ™: The Future of AI-Enabled Scalable QSP Modeling

Immuno-oncology (IO) Simulator in Certara IQ™

ADC Modeling and Design with Certara IQ™

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