Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time-To-Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A [0.03%]
EFANESOCTOCOG ALFA在A型血友病成人，青少年和儿童中的群体药代动力学和出血重复时间分析
Nancy Wong,Pratik Bhagunde,Joakim Nyberg et al.
Nancy Wong et al.
Efanesoctocog alfa is a first-in-class high-sustained factor VIII (HSF) replacement therapy for treatment of hemophilia A. This article presents population pharmacokinetics (PopPK) of efanesoctocog alfa and repeated time-to-event (RTTE) ana...
Population Pharmacokinetics and Exposure-Response Analyses of Sarilumab in Patients with Polymyalgia Rheumatica [0.03%]
在风湿性多肌痛患者中对Sarilumab的人群药代动力学和暴露-反应分析
Christine Xu,William S Denney,Ying Liu et al.
Christine Xu et al.
Sarilumab (interleukin-6 receptor inhibitor) is approved in the United States and Europe for polymyalgia rheumatica (PMR). This study characterized sarilumab pharmacokinetics (PK) and assessed the influence of intrinsic and extrinsic factor...
Cherishing Professional Success and Personal Fulfillment: Resilience as a Pivotal Leadership Competency for Clinical Pharmacologists and Beyond [0.03%]
珍视职业成功与个人满足：作为临床药理学家及更多领域核心领导力的韧性
Karthik Venkatakrishnan,Jing &#x;Daisy&#x; Zhu,Federica Ferrari et al.
Karthik Venkatakrishnan et al.
Resilience is a critical leadership competency directly linked to engagement, sustainable innovation, and productivity. This Commentary presents resilience concepts using the Benatti Resiliency Model®, which comprises five inter-related di...
Optimal Design of Drug-Drug Interaction Studies for the GLP-1 Receptor Agonist Drug Class for Weight Management: Closing a Potential Data Gap [0.03%]
GLP-1受体激动剂类药物减肥药物相互作用研究的最优设计：填补潜在的数据缺口
Elijah Weber,Ashit Trivedi,April M Barbour
Elijah Weber
Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020 [0.03%]
2012-2020年间提交至美国FDA的儿科药物开发试验中的剂量范围研究
Carlton K K Lee,Eugenia Kwon,Francis G Green et al.
Carlton K K Lee et al.
Dose selection is a critical process within pediatric drug development and dose-ranging studies are integral to establish a reasonable dose. The objective of this analysis was to examine the dose-ranging trials utilized in pediatric drug de...
Pharmacokinetics and Safety of Fenofibrate in Participants with Mild Hepatic Impairment or with Advanced Fibrosis due to Metabolic-Associated Fatty Liver Disease [0.03%]
轻度肝功能不全或代谢相关脂肪性肝病所致重度纤维化受试者中非诺贝特的药代动力学和安全性研究
Islam R Younis,Elijah J Weber,Cara Nelson et al.
Islam R Younis et al.
Fenofibrate is contraindicated in patients with advanced hepatic fibrosis due to limited clinical data. We evaluated the pharmacokinetics and safety of fenofibrate in participants with mild hepatic impairment (phase 1 study) or advanced fib...
Contemporary Use of Oral Inotropes in the Outpatient Treatment of Heart Failure: Analysis of a Japanese Nationwide Database [0.03%]
口服正性肌力药物在外心衰门诊治疗中的现代应用：日本全国数据库分析
Michikazu Nakai,Yoshitaka Iwanaga,Koshiro Kanaoka et al.
Michikazu Nakai et al.
Clinical evidence of oral inotrope use for advanced heart failure (HF) is limited. This study investigated the contemporary use and association of oral inotropes with prognosis in the outpatient treatment of advanced HF using a nationwide a...
A Physiologically Based Pharmacokinetic Model of an Oral Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Adults [0.03%]
健康成人口服酪氨酸激酶2抑制剂Deucravacitinib的生理药代动力学模型
Xinyue Chen,Zhoumeng Lin
Xinyue Chen
This study presents the first physiologically based pharmacokinetic (PBPK) model for deucravacitinib, a novel oral selective tyrosine kinase 2 (TYK2) inhibitor approved for treating moderate-to-severe plaque psoriasis. Using GastroPlus, we ...
Comparing the Efficacy of Various Insulin Types: Pharmacokinetic and Pharmacodynamic Modeling of Glucose Clamp Effects in Healthy Volunteers [0.03%]
比较各种胰岛素类型的疗效：健康志愿者葡萄糖钳夹效应的药代动力学和药效学建模
Yi Chien Chang,William J Jusko
Yi Chien Chang
This study compares the pharmacokinetics and efficacy of various subcutaneously (SC) dosed insulin analogs, including rapid-acting, intermediate-acting, long-acting, and regular human insulin, using mechanistic pharmacokinetic (PK) and phar...
Ertapenem in the Context of Hypoalbuminemia: Implications for Critically Ill Patients [0.03%]
低白蛋白血症背景下厄他培南对于重症患者的影响
Micaela Elene Seazzu,M Gabriela Cabanilla
Micaela Elene Seazzu
The global rise in extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E) has created significant challenges in the management of severe infections, including bacteremia. Ertapenem, a once-daily carbapenem with high protein-bind...