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

Blog

Toward Canonical HELM Representations for Sequence-Level Peptide Registration

HELM notation isn't canonical by design, creating duplicate-detection risks across peptide registration and biologics registration…

CertaraSeptember 16, 2026

Poster

Toward Canonical HELM Representations for Sequence-Level Peptide Registration

HELM strings can describe the same peptide multiple valid ways, risking silent registration errors. See…

Jan ChristophersonSeptember 15, 2026

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,…

CertaraSeptember 15, 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

Conference

Pharmacometrics Approach Group in Japan 2026

Danielle PillsburySeptember 11, 2026

Blog

Beyond Simple Allometric Scaling: Why Time-Course Methods Win for First-in-Human Predictions

Simple allometric scaling stops at clearance and volume. See how Dedrick plots and the Wajima…

Danielle PillsburySeptember 11, 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

Live Events

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

October 29, 2026 - 11:00 PM – 2:00 PM

Chara LitouSeptember 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

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

Toward Canonical HELM Representations for Sequence-Level Peptide Registration

Toward Canonical HELM Representations for Sequence-Level Peptide Registration

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

Pharmacometrics Approach Group in Japan 2026

Beyond Simple Allometric Scaling: Why Time-Course Methods Win for First-in-Human Predictions

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

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