Estimand Framework Development for eGFR Slope Estimation and Comparative Analyses Across Various Estimation Methods [0.03%]
eGFR斜率估算及不同估计方法比较分析的估量框架开发
Tuo Wang,Yu Du
Tuo Wang
Chronic kidney disease (CKD) is a global health challenge characterized by progressive kidney function decline, often culminating in end-stage kidney disease (ESKD) and increased mortality. To address the limitations such as the extended tr...
A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities [0.03%]
巴西东南部制药行业中分析质量源于设计实施的调查：挑战与机遇
Bianca C Claro,Erica F Condado,Livia D Prado
Bianca C Claro
Analytical Quality by Design (AQbD) is a systematic approach that integrates quality into method design, ensuring robustness, fitness for purpose, and consistency throughout the lifecycle. This study aimed to assess the current scenario, be...
Innovative Multidimensional Quantitative Benefit-Risk Model for Effective Decision Making in Research and Development for Biopharmaceutical Industry [0.03%]
生物医药行业研发有效决策的创新型多维度定量风险收益模型
Maria E Verdugo,Fabio A Lievano,Melvin S Munsaka et al.
Maria E Verdugo et al.
Medicinal products have benefits and risks that must be carefully balanced to inform decision making. The structured benefit-risk (BR) framework is a powerful approach not only to standardize a holistic BR assessment, but also to incorporat...
Assumption-Agnostic Deep Learning Framework for Holistic Clinical Trial Monitoring [0.03%]
一种假设不可知的深度学习框架，用于全面的临床试验监测
Shaoming Yin,Zheyang Wu,Jianchang Lin
Shaoming Yin
Recently developed machine learning-enabled approaches to quality tolerance limit (QTL) surveillance offer efficiencies over labour-intensive source data verification. However, their reliance on parametric assumptions, restriction to Poisso...
Management of Increasing Complexity of Phase I Trials: A Retrospective Analysis from the Niguarda Cancer Center Phase I Unit [0.03%]
尼瓜尔达癌症中心一期临床试验复杂性增加的管理：一期临床试验单位的回顾性分析
Anna Bombelli,Noemi Salmistraro,Stefano Stabile et al.
Anna Bombelli et al.
Patent Analysis Perspectives on China's Orphan Drug R&D: Status and Technology Characteristics [0.03%]
中国罕见病药物研发的专利分析：现状与技术特征透视
Yang Jiao,Fangzhe Yuan,Tianyu Liu et al.
Yang Jiao et al.
Background: Rare diseases present urgent public health challenges requiring coordinated global efforts. This study analyzes China's orphan drug innovation landscape through patent applications (1995-2023) to identify R&D ...
Kiyohito Nakai
Kiyohito Nakai
In recent years, there has been a significant increase in "drug loss"-the absence of drugs on the Japanese market that are already approved in countries outside of Japan-primarily due to the lack of their development in Japan. There were 86...
Outlook of Cell Gene Therapies Development and Approval from Quality and Regulatory Perspective [0.03%]
从质量与监管角度看细胞基因疗法的研发趋势及审批展望
Carolina Iglesias-Lopez,Antonio Vallano,Antònia Agustí
Carolina Iglesias-Lopez
Shahin Vahora,Bhavesh Patel,Nishant Talati et al.
Shahin Vahora et al.
Viral clearance is a vital procedure in the pharma industry, safeguarding the well-being of drug products by eradicating or inactivating possible viral toxins while manufacturing. This includes a multifaceted method, along with laborious te...
Deficiencies Delaying Prescription Drug Approvals by the U.S. Food and Drug Administration, 2020-2024 [0.03%]
2020至2024年美国食品药品监督管理会批准处方药过程中存在的缺陷问题
Sophie Dilek,Richard H Woods,Jeromie Ballreich et al.
Sophie Dilek et al.