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…

Certara2026 年 9 月 18 日

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…

Certara2026 年 9 月 18 日

Fact Sheet

External Data Accelerator: Your standards-first team and technology for conformant vendor data

Our tech-enabled team embeds standards and validation from day one, so your data lands clean,…

Certara2026 年 9 月 15 日

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

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

Webinar

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

Danielle Pillsbury2026 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

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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

External Data Accelerator: Your standards-first team and technology for conformant vendor data

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 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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