PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials Case Study PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…Jim Gallagher2022 年 4 月 11 日
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…Jim Gallagher2021 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…Jim Gallagher2021 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…Jim Gallagher2021 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…Jim Gallagher2021 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…Jim Gallagher2021 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…Jim Gallagher2021 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…Jim Gallagher2021 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 webdev2016 年 6 月 1 日