Patient-Reported Outcomes Used for Regulatory Approval of Medicines Indicated for the Treatment of Dermatological Diseases Authorized in the European Union Between 1998 and 2024 [0.03%]
1998年至2024年欧盟批准的皮肤病药物中用于监管审批的患者报告结局措施
Eléonore Coenen,Diogo Almeida,Bruno Sepodes et al.
Eléonore Coenen et al.
Background: Patient-reported outcomes (PROs) have gained increasing relevance in medicine approvals, particularly in dermatology, where traditional clinical and laboratory endpoints may not fully capture the patient's exp...
Exploring the Polyethylene Glycol-Modified Drug Patent Landscape by Deep Learning [0.03%]
基于深度学习的聚乙二醇修饰药物专利分析
Tingting Zhang,Dechao Deng,Xiaoming Zhang et al.
Tingting Zhang et al.
Objective: Recently, polyethylene glycol modification has become key to improving biopharmaceutical pharmacokinetics and clinical applicability. This study aims to build a comprehensive analytical framework that integrate...
Defining a Clinically Meaningful Within-Person Change Threshold for the Psychomotor Vigilance Test in Narcolepsy Type 1 [0.03%]
定义第一型发作性嗜睡病患者连续心理运动警惕任务测试的临床意义阈值变化标准的研究
Brian T Harel,Robert H Pietrzak,Shruti Dave et al.
Brian T Harel et al.
Objectives: To establish meaningful within-patient change (MWPC) thresholds for the Psychomotor Vigilance Test (PVT) and evaluate whether treatment with the orexin-2 receptor agonist oveporexton (TAK-861) achieved clinica...
BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity [0.03%]
贝-博因：一种兼顾补剂和迟发毒性剂量优化的设计方法
Kai Chen,Yixuan Zhao,Kentaro Takeda et al.
Kai Chen et al.
The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maximum tolerated dose (MTD) to determining the optimal biologica...
Psychotropic Drug Scheduling and Benzodiazepine Receptor Agonist Prescribing in Japan: An Interrupted Time Series Analysis [0.03%]
关于日本的 psychotropic 药物管控和苯二氮卓受体激动剂处方的中断时间序列分析
Kota Tatsuoka,Shota Hamada,Sayuri Shimizu et al.
Kota Tatsuoka et al.
Background: This study aimed to evaluate the effects of psychotropic drug scheduling, including limiting the days' supply per prescription, on the prescriptions of etizolam and zopiclone, benzodiazepine receptor agonists ...
Clinical and Economic Burden of Diseases with Accelerated Approval Therapies: Evidence of Unmet Patient Need [0.03%]
加速审批疗法治疗疾病的临床和经济负担：未满足患者需求的证据
Hanke Zheng,Shanshan Wang,Jason Shafrin et al.
Hanke Zheng et al.
Background: Some US payers delay coverage for non-oncology treatments approved via the Food and Drug Administration (FDA)'s accelerated approval (AA) pathway. ...
The Changing Landscape of Global Biopharmaceutical Leadership, 2004-2024 [0.03%]
全球生物制药领导力的变迁（2004-2024）
Yevgeniy Feyman,John M O&#x;Brien,Jonathan D Campbell
Yevgeniy Feyman
For several decades, the United States (U.S.) has been the leader in biopharmaceutical advancements. Recently, the U.S. has increased government interventions to limit prices for patent-protected medicines. While it is unclear whether ongoi...
Correction to: BOP2-Comb: Bayesian Optimal Phase II Design for Optimizing Doses and Assessing Contribution of Components in Drug Combinations [0.03%]
BOP2-Comb纠错：药物组合中优化剂量和评估成分贡献的贝叶斯最优II期设计纠正版本
Xiaohan Chi,Ying Yuan,Ruitao Lin
Xiaohan Chi
Published Erratum
Therapeutic innovation & regulatory science. 2026 Aug 1. DOI:10.1007/s43441-026-01024-9 2026
Key Real-World Data Management Practices for Registry Evaluation and Quality Assurance [0.03%]
真实世界数据管理用于注册表评估和质量保证的关键实践
Eurie Choi,Zaoyan Piao,Euna Han
Eurie Choi
Background: Clinical settings generate real-world data (RWD), which offers valuable insights into pharmaceutical effectiveness and safety. Agencies, such as the U.S. Food and Drug Administration (FDA), the European Medici...
Integral Drug-Device Combinations and Medical Device Regulation Article 117: The European Medicines Agency Perspective [0.03%]
整体药械组合产品及其监管 Artículo 117：EMA视角
Pascal Venneugues,Christelle Bouygues,Thomas Girard et al.
Pascal Venneugues et al.
Integral drug-device combinations (iDDCs) are governed in the European Union (EU) under the medicinal products framework, but the medical device part must meet relevant requirements of the medical device framework. This implies increased co...