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

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 Greef2026 年 8 月 24 日

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 Bos2026 年 8 月 3 日

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…

Certara2026 年 4 月 7 日

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 -…

Certara2026 年 3 月 18 日

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…

Certara2026 年 2 月 13 日

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…

Certara2026 年 2 月 11 日

Blog

按时交付：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…

Certara2025 年 12 月 29 日

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

Certara2025 年 11 月 12 日

定量药理学

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

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

按时交付：Why pharmacometrics (pmx) is the anchor of successful regulatory submissions

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

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