Mechanistic Models at the Regulatory Frontier: Insights from EMA’s Qualification of the Simcyp® Simulator On-Demand Webinar 监管前沿的机制模型:来自欧洲药品管理局(EMA)对 Simcyp® Simulator 的认证洞见 The European Medicines Agency (EMA) formally qualified Certara’s Simcyp® Simulator, marking the first and only…Certara2025 年 8 月 4 日
Certara Simcyp® Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling Press Release Certara Simcyp® Simulator 成为首个且唯一获得欧洲药品管理局(EMA)认证的 PBPK 建模软件平台 Certara announces that EMA has formally qualified the Simcyp® Simulator for use in regulatory submissions…Certara2025 年 8 月 4 日
Certara’s Simcyp Educational Webinar Series Part 4: Changes in Drug Absorption after Meals and the Reality of Prediction Using Modeling Approaches [in Japanese] On-Demand Webinar Certara Simcyp 教育网络研讨会系列第 4 部分:餐后药物吸收的变化及基于建模方法的预测现实性[日语] The Japanese educational webinar series provides essential insights into in vitro data analysis and the…Certara2025 年 7 月 30 日
MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines On-Demand Webinar MIDD 策略在临床前和临床转化中的应用:临床药理学家与建模学科的合作 Learn how clinical pharmacologists and modeling experts collaborate to improve preclinical-to-clinical translation.Certara2025 年 7 月 29 日
Boosting Confidence in Drug Discovery with PBPK On-Demand Webinar 通过 PBPK 模型提升药物发现的信心 了解 Simcyp Discovery 第 2 版的更新内容,助力早期药物研发。Certara2025 年 7 月 25 日
AusBiotech International Conference 2025 Conference AusBiotech International Conference 2025 Certara2025 年 7 月 25 日
The end of animal testing? Transitioning to models is promising — but no silver bullet Press Coverage 动物实验的终结?转向模型研究充满希望,但并非万能良方 The FDA has stated that the pharma industry must transition to using in vitro assays,…Certara2025 年 7 月 21 日
Certara’s Simcyp Educational Webinar Series Part 3: Understanding the Supersaturated Dissolution in the Digestive Tract with Modeling & Simulation Approaches [in Japanese] On-Demand Webinar Certara Simcyp 教育网络研讨会系列第 3 部分:利用建模与模拟方法理解消化道中的过饱和溶解现象[日语] Learn PBBM fundamentals and supersaturated dissolution modeling in Japanese with Dr. Kambayashi—ideal for CMC and…Certara2025 年 7 月 16 日
制药行业是如何应对全球健康不平等问题的? 新闻报导 制药行业是如何应对全球健康不平等问题的? Explore Karen Rowland Yeo's insights on using Model-Informed Drug Development to address global health equities…Certara2025 年 6 月 17 日
Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance On-Demand Webinar 模型引导的药物开发(MIDD)的监管环境演变:ICH M15 指南草案的影响 We explore the evolving regulatory landscape for Model-Informed Drug Development (MIDD), focusing on the impact…Certara2025 年 5 月 23 日