Press Coverage

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

Explore insights from Certara experts on how PK/PD modeling streamlines biologic drug development.

CertaraAugust 5, 2025

Blog

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

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

On-Demand Webinar

MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines

Learn how clinical pharmacologists and modeling experts collaborate to improve preclinical-to-clinical translation.

CertaraJuly 29, 2025

On-Demand Webinar

Boosting Confidence in Drug Discovery with PBPK

Explore Simcyp Discovery Version 2 updates to boost early-stage drug development.

CertaraJuly 25, 2025

Conference

AusBiotech International Conference 2025

CertaraJuly 25, 2025

Press Coverage

The end of animal testing? Transitioning to models is promising — but no silver bullet

The FDA has stated that the pharma industry must transition to using in vitro assays,…

CertaraJuly 21, 2025

On-Demand Webinar

Certara’s Simcyp Educational Webinar Series Part 3: Understanding the Supersaturated Dissolution in the Digestive Tract with Modeling & Simulation Approaches [in Japanese]

Learn PBBM fundamentals and supersaturated dissolution modeling in Japanese with Dr. Kambayashi—ideal for CMC and…

CertaraJuly 16, 2025

Certara Products – Simcyp

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

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

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

MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines

Boosting Confidence in Drug Discovery with PBPK

AusBiotech International Conference 2025

The end of animal testing? Transitioning to models is promising — but no silver bullet

Certara’s Simcyp Educational Webinar Series Part 3: Understanding the Supersaturated Dissolution in the Digestive Tract with Modeling & Simulation Approaches [in Japanese]

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