Jim Gallagher, Author at Certara | 第 17 页，共 25 页

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

Shire

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

Neurvati

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

AstraZeneca

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

Novartis

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

Sanofi

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

PTC Therapeutics

Case Study

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Jim Gallagher2021 年 8 月 20 日

White Paper

FDA 的数字化转型之旅

Jim Gallagher2021 年 8 月 19 日

White Paper

使用经临床验证的计算机建模和模拟进行免疫原性预测和剂量优化

Jim Gallagher2021 年 8 月 19 日

Article

全新 FDA 指南 Project Optimus 可能如何影响肿瘤学临床试验和药物研究计划的未来

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…

Jim Gallagher2021 年 8 月 16 日

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