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 Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定 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 Simcyp Simulatorを使用するDDIレギュレトリーの広告塔: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 鎌状赤血球症治療用のVoxelotor:用量予測モデルを活用して臨床試験を実施することなくDDIを予測 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 ガルデルマ社、AKLIEF®(トリファロテン)のFDA承認を取得 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