Simcyp Simulator Becomes First EMA PBPK Qualified Platform
🕓 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...