Model Informed Drug Development Archives

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Improve pediatric drug development with Certara’s Pediatric Practice, MIDD expertise for PIPs/PSPs, dose selection, regulatory…

CertaraNovember 10, 2025

Guide

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic Development

Learn how Early Feasibility Assessment and QSP modeling improve drug design, de-risk feasibility studies, &…

CertaraNovember 7, 2025

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

Model Informed Drug Development

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

De-Risking Drug Design: How Early Feasibility Assessment Transforms Biotherapeutic 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

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