Model Informed Drug Development Archives

Blog

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…

CertaraMarch 24, 2026

Publication

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…

Danielle PillsburyMarch 24, 2026

Publication

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

This article describes how a model-informed drug development (MIDD) approach was used to support the…

CertaraMarch 24, 2026

Blog

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

Learn how regulatory expectations in clinical pharmacology are evolving and how to build a strategy…

CertaraMarch 24, 2026

Webinar

Pharmacometrics Under Pressure

CertaraMarch 20, 2026

Guide

Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer

Download Certara’s expert guide on pharmacometrics and pediatric drug development. Learn how modeling, MIDD, and…

CertaraMarch 19, 2026

Conference

Discovery & Development Europe 2026

CertaraMarch 13, 2026

Blog

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…

CertaraMarch 11, 2026

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 2026

Blog

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

Model Informed Drug Development

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

Pharmacometrics Under Pressure

Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer

Discovery & Development Europe 2026

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

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