PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Case Study PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…Becca Bucci2022 年 6 月 2 日
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
Certara’s Simcyp Simulator Demo Video Certara Simcyp Simulator 演示 The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK…Jim Gallagher2022 年 1 月 20 日
Essentials of Model-informed Drug Development (MIDD) – Top-down vs. Bottom-up Approaches Blog 模型引导的药物开发 (MIDD) 要点—自上而下与自下而上的方法对比 How can the latest modeling and simulation technologies accelerate drug discovery and development? We frequently…Jim Gallagher2021 年 9 月 2 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
Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates Case Study Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being…Jim Gallagher2021 年 8 月 26 日
Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Case Study Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to…Jim Gallagher2021 年 8 月 26 日
Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Case Study Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…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
Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Case Study Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Jim Gallagher2021 年 8 月 20 日