Publication

When EV Dose Is Not What It Seems: Quantitative Mismatch Between Particle Number- and Protein-Based Dosing

Research shows that particle- and protein-based extracellular vesicle dosing are not interchangeable, supporting a multidimensional…

CertaraSeptember 18, 2026

Publication

Semi-Mechanistic Joint Population Pharmacokinetic Modeling of the Novel Antituberculosis Drug Sorfequiline and Its Metabolite M3 in Healthy Volunteers

A semi-mechanistic population PK model characterizes sorfequiline and its active M3 metabolite to support DDI…

CertaraSeptember 18, 2026

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…

CertaraSeptember 14, 2026

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 PillsburySeptember 9, 2026

Guide

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

Build the governance, capabilities, and cross-functional alignment that turn MIDD evidence into decision-ready evidence under…

Rik de GreefSeptember 9, 2026

Guide

A Best Practice Guide to Validation in Clinical Data Management

Learn best practices for software validation in research settings with this guide to validation in…

Danielle PillsburySeptember 2, 2026

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…

CertaraAugust 28, 2026

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…

CertaraAugust 28, 2026

Webinar

The Road to First-in-Human: Model-Informed Decisions from Discovery to First Dose

Danielle PillsburyAugust 28, 2026

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 PillsburyAugust 28, 2026

Drug Development

When EV Dose Is Not What It Seems: Quantitative Mismatch Between Particle Number- and Protein-Based Dosing

Semi-Mechanistic Joint Population Pharmacokinetic Modeling of the Novel Antituberculosis Drug Sorfequiline and Its Metabolite M3 in Healthy Volunteers

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

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

A Best Practice Guide to Validation in Clinical Data Management

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

The Road to First-in-Human: Model-Informed Decisions from Discovery to First Dose

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

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