From clinical data management to clinical data science: Time for a new educational model [0.03%]
从临床数据管理到临床数据科学：是时候建立新的教育模式了
Richard F Ittenbach
Richard F Ittenbach
The purpose of this article is to propose and provide a blueprint for a graduate-level curriculum in clinical data science, devoted to the measurement, acquisition, care, treatment, and inferencing of clinical research data. The curriculum ...
A phase I, open-label, single-dose study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of futibatinib [0.03%]
一项I期、开放标签、单次递增剂量研究，评估肝功能不全受试者接受福泰班替滨后的药代动力学和安全性
Ling Gao,Ikuo Yamamiya,Mark Pinti et al.
Ling Gao et al.
Futibatinib is a covalently binding FGFR1-4 inhibitor that received US Food and Drug Administration approval for the treatment of patients with previously treated, advanced intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearra...
Clinical characteristics in early Parkinson's disease with excessive daytime sleepiness: A cross-sectional and longitudinal study [0.03%]
帕金森病早期日间过度嗜睡患者的临床特征：横断面及纵向研究
Yumei Liu,Ling Xue,Jun Zhao et al.
Yumei Liu et al.
We aimed to explore excessive daytime sleepiness (EDS) and correlates of clinical characteristics by using cross-sectional and longitudinal analyses from the Parkinson's Progression Markers Initiative database. Four hundred twenty-three pat...
Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020 [0.03%]
2002至2020年美国FDA药物申请中局部用药的儿科剂量研究
Gelareh A Abulwerdi,Anuradha Ramamoorthy,Edward Bashaw et al.
Gelareh A Abulwerdi et al.
Deriving pediatric doses for locally acting drugs (LADs) presents a unique challenge because limited systemic exposure hinders commonly used approaches such as pharmacokinetic matching to adults. This study systematically evaluated drug dev...
A randomized, controlled single, and multiple ascending dose trial of the safety, pharmacokinetics and pharmacodynamics of SN1011 in healthy subjects [0.03%]
SN1011在健康受试者中的I期随机、双盲、安慰剂对照的单次和多次给药剂量递增试验：药物动力学及作用机制研究
Leilei Zhu,Rong Shi,Tongfang Zhao et al.
Leilei Zhu et al.
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SN1011, a novel Bruton tyrosine kinase (BTK) inhibitor, and food effects in healthy subjects. In this phase I trial, subjects r...
CYP2C19 loss-of-function alleles and use of omeprazole or esomeprazole increase the risk of cardiovascular outcomes in patients using clopidogrel [0.03%]
CYP2C19功能丧失型等位基因与氯吡格雷联用奥美拉唑或艾司奥美拉唑增加患者心血管结局风险
Markus Ramste,Markus Ritvos,Sergei Häyrynen et al.
Markus Ramste et al.
Our aim was to investigate in a real-life prospective patient cohort how CYP2C19 loss-of-function (LOF) variants and CYP2C19 inhibitor omeprazole or esomeprazole influence the incidence of cardiovascular events in patients using clopidogrel...
Wouter Ten Voorde,Chika Akinseye,Ismahaan Abdisalaam et al.
Wouter Ten Voorde et al.
Pharmacological challenge models are deployed to evaluate drug effects during clinical development. Intradermal injection of Substance P (SP) neuropeptide, a potential challenge agent for investigating local mediators, is associated with wh...
Drug-drug interaction study of ciprofol and sodium divalproex: Pharmacokinetics, pharmacodynamics, and safety in healthy Chinese subjects [0.03%]
环丙泊酚与碳酸戊乙酯的药物相互作用研究：健康中国受试者的药代动力学、药效学和安全性
Dandan Yang,Wei Zhang,Zourong Ruan et al.
Dandan Yang et al.
Ciprofol (also known as HSK3486) is a promising intravenous anesthetic candidate derived from propofol and independently developed by Haisco Pharmaceutical Group Co., Ltd. (Chengdu, China). Compared with propofol, ciprofol has the potential...
Keverprazan, a novel potassium-competitive acid blocker: Multiple oral doses safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects [0.03%]
新型钾竞争性酸阻滞剂钾竞争性酸阻滞剂(Keverprazan)的多次口服安全性、耐受性、药动学和药效学研究：健康志愿者研究表明
Sufeng Zhou,Lijun Xie,Chen Zhou et al.
Sufeng Zhou et al.
Keverprazan, a novel potassium-competitive acid blocker, was approved for treating acid-related diseases. This study aimed to analyze the safety, pharmacokinetics (PKs) and pharmacodynamics (PDs) of multiple doses of keverprazan. This was a...
Randomized Controlled Trial
Clinical and translational science. 2023 Oct;16(10):1911-1922. DOI:10.1111/cts.13598 2023
Areas of strength and opportunities for growth in translational science education and training: Results of a scoping review from the NCATS Education Branch [0.03%]
转化科学教育和培训的强项与成长机遇：国家转化科学促进中心教育部门范围审查结果
Amanda L Vogel,Brittany M Haynes,Shadab F Hussain et al.
Amanda L Vogel et al.
Translational science education and training (E&T) aims to prepare the translational workforce to accelerate progress along the translational pipeline toward solutions that improve human health. In 2020-2021, the National Center for Advanci...