Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials Case Study アシミニブ ― PBPK モデリングが開発を効率化し、10件以上の臨床試験を回避 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 Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator 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 A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator 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ガイドラインと薬物相互作用評価パッケージの整備について 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
Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy Case Study Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about…Certara2022年10月31日
Why you should select your drug formulation before starting clinical studies Blog 臨床試験を開始する前に製剤を選択すべき理由 創薬企業はしばしば、ヒトでの試験を急ぐあまり、創薬プロセスを駆け足で進めてしまうことがあります。Most are…Certara2022年10月28日
Simcyp Discovery Simulator Brochure Simcyp Discovery Simulator (シムシップ・ディスカバリー・シミュレーター) Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers…Certara2022年7月14日
Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease Case Study Simcyp Simulatorが希少疾患の成人および青少年における薬物投与の最適化を支援 先天性副腎過形成症(CAH)は、世界中でおよそ400,000人の患者さんがいます。Current therapy for CAH uses a…Certara2022年6月6日