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 ® ...
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 ...
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 ...
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 ...
manilatimes

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 ...
ascopubs.org

A physiologically-based pharmacokinetic (PBPK) and pharmacodynamic (PD) model of docetaxel (Doc) and neutropenia in humans

Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: Results from randomized EORTC 05011 trial ...
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 ...