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
Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin Publication Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…Certara2013 年 9 月 1 日
A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine Publication A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…Certara2013 年 7 月 24 日