Changes in Saccadic Hypometria over Time to Monitor Parkinson's Disease Progression [0.03%]
随时间变化的扫视不足量的变化监测帕金森病的发展状况
Edmund Ben-Ami,Eitan Raveh,Eran Harpaz et al.
Edmund Ben-Ami et al.
Background: Eye movement biomarkers are emerging as promising tools for monitoring neurodegenerative diseases in clinical trials. Saccadic hypometria, the reduced saccade amplitude leading to undershooting visual targets,...
Evaluation of the Quality Decision-Making Practices Utilized by the Zambia Medicines Regulatory Authority Technical Committees [0.03%]
评价赞比亚药品监管局技术委员会的质量决策实践质量
Constance Sakala Chisha,Makomani Siyanga,Stephanie Leigh et al.
Constance Sakala Chisha et al.
Background: A consistent and transparent approach is essential for quality decision-making in the review and approval of medicines. This is achieved through the use of a standard and well-defined framework, as the decisio...
Susan M Abdel-Rahman,Yutao Gong,Caleb Choi et al.
Susan M Abdel-Rahman et al.
Background and objectives: Lagging pediatric safety and effectiveness data increase the risks to children associated with off-label drug use. The objective of this study was to delineate the frequency of, and reasons behi...
Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive Analysis [0.03%]
欧盟临床试验新法规下的儿科I/II期临床试验评估：一项描述性分析
Laura Fankhauser,Franca Ligas,Giovanni Lesa et al.
Laura Fankhauser et al.
Background: Children remain underrepresented in clinical research, despite regulatory frameworks like the EU Paediatric Regulation and Paediatric Investigation Plans (PIPs). The 2024 Declaration of Helsinki revision now r...
Transformation of a Medical Information Department to Meet the New Healthcare Realities of the Post-Pandemic Era [0.03%]
后疫情时代转型适应新的医疗卫生环境的医学信息科
Almudena Rovirosa,Sara Jericó,Ana Muñiz et al.
Almudena Rovirosa et al.
The role of Medical Information in the pharmaceutical industry is undergoing a profound transformation, driven by evolving stakeholder expectations, digital innovation, and the increasing complexity of therapeutic landscapes. Traditionally ...
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation [0.03%]
一种具有口味掩蔽和剂量灵活性的儿童多单元固体分散制剂的开发：以克唑替尼为研究对象的案例分析
Jeremy A Bartlett,Natalie Culver,Matt Santangelo et al.
Jeremy A Bartlett et al.
Background: Developing pediatric dosage forms remains challenging, particularly for poorly palatable drugs, which can limit tolerability and adherence. Crizotinib, an anaplastic lymphoma kinase inhibitor used to treat rar...
Association Between Survival Benefits of Anticancer Drugs and Probability of US Food and Drug Administration Approval: A Systematic Review [0.03%]
抗癌药物的生存益处及其获得美国食品药品监督管理局批准的概率之间的关系：系统性综述
Koji Ishizuka,Shunsuke Ono
Koji Ishizuka
BACKGROUND AND OBJECTIVES: Survival benefit constitutes the primary pillar of therapeutic efficacy in oncology. However, the survival benefits observed in registrational trials broadly range from significant to marginal, even for US Food an...
The Combat Against Antimicrobial Resistance: An Overview of EU Recent Health Policies and Drug Regulations Promoting the Development of New Antimicrobials [0.03%]
对抗微生物耐药性的斗争：促进新型抗菌药物研发的欧盟近期卫生政策和药品监管综述
Lena Daher,Ingrid Vilimelis-Piulats
Lena Daher
Antimicrobial resistance, including antibiotic resistance, constitutes a major global public health threat. In Europe, antimicrobial resistance is recognized among the top three health threats, in line with the World Health Organization's p...
38th Congress of the European College of Neuropsychopharmacology (ECNP 2025) [0.03%]
第38届欧洲神经精神药理学学院年会(ECNP 2025)
Alma Orts-Sebastian
Alma Orts-Sebastian
Shaping the Future of Evidence Generation: Real-World Data to Drive Healthcare Transformation and Patient-Centered Decisions [0.03%]
塑造证据生成的未来：利用真实世界数据推动医疗转型和以患者为中心的决策
Jesús Medina,Joaquín Sánchez-Covisa,Javier Nuevo et al.
Jesús Medina et al.
The increasing complexity of healthcare decision making and the demand for real-world evidence call for a transformation in how Medical Affairs departments generate and communicate evidence. In response, AstraZeneca Spain implemented a stru...