Posts

Showing posts with the label PBPK modeling software

Archive

Show more

Simcyp Simulator Becomes First EMA PBPK Qualified Platform

Image
🕓 Estimated Reading Time: 5 minutes Overview In a landmark decision that promises to redefine the landscape of pharmaceutical development, Certara’s Simcyp Simulator has become the first and only software platform to receive a Qualification Opinion from the European Medicines Agency (EMA) for Physiologically Based Pharmacokinetic (PBPK) modeling. This pivotal Simcyp EMA qualification marks a significant stride in the adoption of advanced simulation technologies for drug development and regulatory submissions across Europe. The announcement, made by Certara, highlights a growing acceptance and reliance on sophisticated computational tools to enhance the efficiency, safety, and predictability of new medicines. Background & Context For decades, drug development has been a resource-intensive, time-consuming, and often unpredictable endeavor, heavily reliant on extensive in vitro and in vivo studies. PBPK modeling represents a paradigm shift, offering a mechanistic approach to predict...

Popular posts from this blog

Toto Wolff Sells Mercedes F1 Stake George Kurtz Invests

ACND Approves Budget, Rates, and Infrastructure Grants

NVIDIA Earnings Impress AI Market Continues Surge

SwitchBot RGBICWW Smart LED Strip Arrives with Apple Home

WeRide Robotaxi Revenue Surges 836% Amid Global Expansion

Top Video Game Stocks to Research Right Now

Space-Based Network Market Projected to Reach $50 Billion

Cloudian Simplifies AI Data Storage Needs

Princeton Secures State Grant for First Multi-Purpose Field

Top Robot Vacuums Expert Picks for Your Home