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Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

The Simcyp Simulator receives EMA qualification—the first and only PBPK platform formally qualified for any…

CertaraAugust 5, 2025

On-Demand Webinar

Mechanistic Models at the Regulatory Frontier: Insights from EMA’s Qualification of the Simcyp® Simulator

The European Medicines Agency (EMA) formally qualified Certara’s Simcyp® Simulator, marking the first and only…

CertaraAugust 4, 2025

Press Release

Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling

Certara announces that EMA has formally qualified the Simcyp® Simulator for use in regulatory submissions…

CertaraAugust 4, 2025

On-Demand Webinar

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

CertaraAugust 1, 2025

Blog

Machine Learning (ML) in healthcare

Learn about 3 distinct examples of machine learning (ML) in healthcare that utilize different techniques…

CertaraAugust 1, 2025

Press Release

Certara Appoints Dr. Chris Bouton as Chief Technology Officer to Advance AI in-silico Drug Discovery and Development Platform

Strengthening technology innovation and leadership of the Certara AI/ML-enabled biosimulation platform used to speed time…

CertaraJuly 31, 2025

Blog

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

CertaraJuly 31, 2025

On-Demand Webinar

Certara’s Simcyp Educational Webinar Series Part 4: Changes in Drug Absorption after Meals and the Reality of Prediction Using Modeling Approaches [in Japanese]

The Japanese educational webinar series provides essential insights into in vitro data analysis and the…

CertaraJuly 30, 2025

Blog

Recapping a record-breaking 2025 Krakow HTA Symposium

We cover the key takeaways from CERTAINTY 2025, including the power of Model-Informed Drug Development…

Simona ColucciJuly 30, 2025

Case Study

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Certara supported DMD drug development for Givinostat, helping Italfarmaco with pharmacometric and regulatory strategy.

CertaraJuly 29, 2025

Breaking New Ground: EMA Qualification of the Simcyp® Simulator Ushers in a New Era for PBPK Modeling

Mechanistic Models at the Regulatory Frontier: Insights from EMA’s Qualification of the Simcyp® Simulator

Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

Machine Learning (ML) in healthcare

Certara Appoints Dr. Chris Bouton as Chief Technology Officer to Advance AI in-silico Drug Discovery and Development Platform

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

Certara’s Simcyp Educational Webinar Series Part 4: Changes in Drug Absorption after Meals and the Reality of Prediction Using Modeling Approaches [in Japanese]

Recapping a record-breaking 2025 Krakow HTA Symposium

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

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