Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Case Study 使用 Simcyp Simulator 确定 Guanfacine 在儿童中的药物相互作用风险 Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…Certara2021 年 8 月 26 日
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…Certara2021 年 8 月 26 日
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…Certara2021 年 8 月 12 日
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…Certara2021 年 8 月 12 日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study 使用 Simcyp Simulator 的 DDI 监管典范案例:Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…Certara2021 年 7 月 29 日
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study 治疗镰状细胞病的 Voxelotor:无需任何临床研究,利用剂量预测模型进行 DDI 预测 In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…Certara2021 年 7 月 14 日
Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure On-Demand Webinar Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and…Certara2021 年 4 月 1 日
Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Case Study Galderma AKLIEF®(曲法罗汀)获得了 FDA 批准 In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…Certara2020 年 11 月 9 日
Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions Publication Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions Certara2016 年 6 月 1 日
Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko Blog Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…Certara2015 年 12 月 1 日