Publication

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

New CPT review by Certara's Karen Rowland Yeo & Piet van der Graaf shows how…

Danielle PillsburySeptember 23, 2026

White Paper

Model-Informed Strategies for ADC Development

Explore how model informed drug development can help ADC developers optimize dosing, reduce uncertainty, strengthen…

Danielle PillsburySeptember 22, 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

Live Events

An Introduction to Fast and Reliable Modeling with RsNLME and Agentic AI

CertaraSeptember 1, 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

Modeling and Simulation

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

Model-Informed Strategies for ADC Development

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

An Introduction to Fast and Reliable Modeling with RsNLME and Agentic AI

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

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