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…

Certara2026年9月14日

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

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 Pillsbury2026年7月7日

Case Study

サターラはいかにして、転移性大腸がん治療薬FruquintinibのFDA承認取得を支援したか

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

　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

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ファーマコメトリクス

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

サターラはいかにして、転移性大腸がん治療薬FruquintinibのFDA承認取得を支援したか

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)

From “wild west” to model-informed confidence

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