药物制造者：生物模拟时代

The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as the FDA moves to phase out mandatory animal testing. Highlighting insights from Patrick Smith, Senior Vice President of Translational Sciences at Certara, the piece unpacks how AI-driven biosimulation combines biological, pharmacokinetic, and molecular data to enable model-informed drug development, improve precision, and accelerate progress. It delves into the challenges of regulatory acceptance, the integration of in silico data, and the potential to replace animal testing. Additionally, it details specific use cases, including pediatric epilepsy dosing, and discusses the increasing flexibility and role of biosimulation across drug development stages.