Business Wire

Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, N.J.--(BUSINESS WIRE)--Certara ® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp ® ...
Yahoo Finance

Simulations Plus (SLP) Launches GPX to Advance PBPK Modeling

Simulations Plus SLP announced the launch of GastroPlus X (GPX), which is its latest platform for physiologically based pharmacokinetics and biopharmaceutics (PBPK/PBBM) modeling and simulation. The ...
Nasdaq

Certara Unveils Simcyp V24, Enhancing Drug Development With Advanced PBPK Modeling

(RTTNews) - Certara, Inc. (CERT),on Tuesday announced the release of Simcyp Simulator Version 24, enhancing physiologically-based pharmacokinetic or PBPK modeling to support drug development and ...
Medical Device and Diagnostic Industry (MD+DI)

Computer-Aided Clinical Trials for Medical Devices: From Research to Reality

The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional ...
Yahoo Finance

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

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator ...
Business Wire

Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables

LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and ...
JSTOR Daily

PBPK Modeling/Monte Carlo Simulation of Methylene Chloride Kinetic Changes in Mice in Relation to Age and Acute, Subchronic, and Chronic Inhalation Exposure

Using physiologically based pharmacokinetic (PBPK) modeling coupled with Monte Carlo simulation and bootstrap resampling for data analyses, a significant induction in the mixed function oxidase (MFO) ...
Healthcare Dive

Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA ANDA approval PRINCETON, NJ – June ...