Poster

Pharmacometric Analysis of Givinostat to Support Individualized Dosing Recommendations in Pediatric Patients with Duchenne Muscular Dystrophy

Pharmacometric modeling of givinostat in pediatric DMD supported a simplified 4-band weight-based dosing regimen without…

Certara2026年9月14日

Publication

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development

A new paper argues context of use, not NAMs-versus-animals, should govern nonclinical strategy in drug…

Danielle Pillsbury2026年9月9日

Live Events

Tailwinds for MIDD: EMA, FDA, and a Converging Regulatory Landscape

2026年10月29日 - 11:00 PM – 2:00 PM

Certara2026年9月9日

Guide

From Models to Decisions: Building MIDD Readiness in the Era of ICH M15

Explore what ICH M15 means for Model-Informed Drug Development and learn how to build MIDD…

Rik de Greef2026年9月9日

Publication

A glimpse into the future of model-informed drug discovery and development

Explore the future of Model-Informed Drug Development (MIDD), including advances in pharmacometrics, PBPK, QSP, precision…

Certara2026年8月28日

Publication

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

Explore how model-based tumor growth inhibition metrics can support earlier Go/No-Go decisions and pivotal trial…

Certara2026年8月28日

Case Study

De-Risking Phase 3 Rheumatoid Arthritis Trials with Model-Based Meta-Analysis (MBMA)

Learn how Model-based meta-analysis (MBMA) helped optimize Phase 3 trial design, dose selection, and development…

Danielle Pillsbury2026年8月28日

Blog

The five drug development questions that bring sponsors to pharmacometrics

Sponsors rarely come to pharmacometrics because they need a model. They come with a development…

Rik de Greef2026年8月24日

Webinar

Beyond Trial and Error: Model-Informed Formulation Development in Practice

Siri Kalyan Chirumamilla2026年8月24日

Fact Sheet

Model-Based Meta-Analysis (MBMA): Real-World Examples

See real-world examples of how model-based meta-analysis (MBMA) uses existing clinical evidence to predict trial…

Certara2026年8月24日

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モデルに基づく医薬品開発

Pharmacometric Analysis of Givinostat to Support Individualized Dosing Recommendations in Pediatric Patients with Duchenne Muscular Dystrophy

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development

Tailwinds for MIDD: EMA, FDA, and a Converging Regulatory Landscape

From Models to Decisions: Building MIDD Readiness in the Era of ICH M15

A glimpse into the future of model-informed drug discovery and development

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

De-Risking Phase 3 Rheumatoid Arthritis Trials with Model-Based Meta-Analysis (MBMA)

The five drug development questions that bring sponsors to pharmacometrics

Beyond Trial and Error: Model-Informed Formulation Development in Practice

Model-Based Meta-Analysis (MBMA): Real-World Examples

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