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

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

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 GreefAugust 24, 2026

Blog

RsNLME meets MCP: the pharmacometric AI assistant scientists have been asking for

Discover RsNLME's new MCP server: an AI assistant that understands both pharmacometric science and PML/R…

Arjen BosAugust 3, 2026

Publication

Population pharmacokinetic analysis and exposure–response analysis of brexpiprazole in Japanese patients with agitation in Alzheimer’s dementia

Explore how population pharmacokinetic and exposure–response modeling informed brexpiprazole dosing in Japanese patients with agitation…

CertaraJuly 16, 2026

Publication

Population PK Modeling Supporting the Aripiprazole Two-Injection Start Regimen in Japanese Patients

Learn how population PK modeling and simulation supported a regulatory strategy for a simplified aripiprazole…

Danielle PillsburyJuly 7, 2026

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

CertaraApril 7, 2026

Pharmacometrics

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

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 five drug development questions that bring sponsors to pharmacometrics

RsNLME meets MCP: the pharmacometric AI assistant scientists have been asking for

Population pharmacokinetic analysis and exposure–response analysis of brexpiprazole in Japanese patients with agitation in Alzheimer’s dementia

Population PK Modeling Supporting the Aripiprazole Two-Injection Start Regimen in Japanese Patients

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

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