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 ® ...

Javelin Biotech and Pfizer Announce Landmark Publication Demonstrating Clinical PK Predictions Using Multi-Tissue Chip Platform

Javelin Biotech today announced a landmark scientific publication, titled "Interconnected multi-microphysiological systems ...
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 ...
Nasdaq

FDA grants Simulations Plus to use PBPK to expand mechanistic modeling for LAI

Simulations Plus (SLP) announced that it has been awarded a newly funded grant from the U.S. Food and Drug Administration FDA to use physiologically based pharmacokinetic PBPK approaches in GastroPlus ...
EurekAlert!

PBPK model precisely predicts drug–drug interactions between prodrug GP681 and CYP3A4 inhibitors, offering new guidance for safe influenza therapy

Suraxavir marboxil (GP681) is an orally available prodrug that is converted in vivo to the active metabolite GP1707D07, a PA-targeting antiviral against influenza. Because GP1707D07 is primarily ...
Nature

Reverse dosimetry: interpreting trihalomethanes biomonitoring data using physiologically based pharmacokinetic modeling

Biomonitoring data provide evidence of exposure of environmental chemicals but are not, by themselves, direct measures of exposure. To use biomonitoring data in understanding exposure, physiologically ...
National Academies of Sciences%2c Engineering%2c and Medicine

Acute Exposure Guideline Levels for Selected Airborne Chemicals: Volume 9

This White Paper describes the guidance that is proposed for use in the integration of physiologically based pharmacokinetic (PBPK) modeling in risk assessment in the EPA Acute Exposure Guideline ...
Business Wire

Certara Releases Simcyp™ PBPK Simulator Version 20, Including Newly Expanded Biologics Software

PRINCETON, N.J.--(BUSINESS WIRE)--Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator ...
Nature

Simulation of the pharmacokinetics of bisoprolol in healthy adults and patients with impaired renal function using whole-body physiologically based pharmacokinetic modeling

To develop and evaluate a whole-body physiologically based pharmacokinetic (WB-PBPK) model of bisoprolol and to simulate its exposure and disposition in healthy adults and patients with renal function ...
Finanznachrichten

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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Human Biomonitoring for Environmental Chemicals

Physiologically based pharmacokinetics (PBPK), as the name implies, is a special branch of pharmacokinetics where physiology and anatomy of the animal or human body, as well as the biochemistry of the ...