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 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

Blog

ICH M15 guideline: What the finalized guideline means for model-informed drug development

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraMarch 18, 2026

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

CertaraFebruary 13, 2026

Blog

Pediatric drug development: From “wild west” to model-informed confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

CertaraFebruary 11, 2026

Blog

Delivering on deadline: Why pharmacometrics (pmx) is the anchor of successful regulatory submissions

Explore how PMx regulatory submissions, exposure-response modeling, and strategic pharmacometrics planning support successful and timely…

CertaraDecember 29, 2025

Pharmacometrics

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

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

ICH M15 guideline: What the finalized guideline means for model-informed drug development

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Pediatric drug development: From “wild west” to model-informed confidence

Delivering on deadline: Why pharmacometrics (pmx) is the anchor of successful regulatory submissions

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