Real-world application of physiologically based pharmacokinetic models in drug discovery Publication 基于生理的药代动力学(PBPK)模型在药物研发中的实际应用 The utility of physiologically based pharmacokinetic (PBPK) models in support of drug development has been…Danielle Pillsbury2024 年 11 月 22 日
Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women Publication 定量药理学和系统药理学方法在改善和优化孕妇和哺乳期妇女药物治疗方面的最新应用 The article "Recent Applications of Pharmacometrics and Systems Pharmacology Approaches to Improve and Optimize Drug…Danielle Pillsbury2024 年 11 月 18 日
Simcyp™ PBPK Simulator | Predicting Drug Performance Video Simcyp™ PBPK Simulator | 预测药物性能 Certara2024 年 9 月 26 日
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…Simona Colucci2024 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).Simona Colucci2024 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.…Danielle Pillsbury2024 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…Danielle Pillsbury2024 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…Danielle Pillsbury2024 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