Waiving clinical studies & accelerating drug development for kinase inhibitor drugs eBook 免除激酶抑制剂药物的临床研究并加快药物开发 Whether you're in pre, early, or late clinical stages, this eBook offers real-world insights into…Certara2024 年 8 月 28 日
PBPK Applications (MIFD) Using the Simcyp™ Simulator eBook 使用 Simcyp™ Simulator 的 PBPK 应用(MIFD) Explores strategies, regulatory validation, and solutions in small-molecule human Physiologically Based Pharmacokinetic modeling (PBPK).Certara2024 年 8 月 28 日
Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials Case Study Asciminib — 模型简化了研发过程,避免了 10 多项临床试验 Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML.…Certara2024 年 8 月 27 日
Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator Publication 预测涉及抑制作用的 CYP 介导的 DDIs:满足 Simcyp Simulator 系统鉴定要求的方法 The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…Certara2024 年 8 月 26 日
A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator Publication 在 Simcyp Simulator 中开发基于生理的药代动力学模型人群文件指南 This collaborative effort by Certara and the Centre for Applied Pharmacokinetic Research (CAPKR) at The…Certara2024 年 7 月 24 日
ICH M12 Guidelines & Your Drug-Drug Interaction Package Blog ICH M12 指南与药物相互作用资料 We have provided an overview of the key changes to the ICH M12 drug-drug interaction…Certara2024 年 6 月 19 日
Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator Fact Sheet Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies…Certara2023 年 12 月 6 日
American College of Toxicology 2025 Annual Meeting Conference American College of Toxicology 2025 Annual Meeting – – BoothCertara2023 年 5 月 24 日