Bohua Chen,Lucia Chantal Schneider,Christian Röver et al.
Bohua Chen et al.
In the context of clinical research, computational models have received increasing attention over the past decades. In this systematic review, we aimed to provide an overview of the role of so-called in silico clinical trials (ISCTs) in med...
Regulatory Challenges and Opportunities: A Review of U.S. Food and Drug Administration-Approved Artificial Intelligence and Machine Learning-Enabled Cardiovascular Devices [0.03%]
机遇与挑战并存：美国食品药品监督管理局批准的心脏病人工智能和机器学习设备回顾
Mahima Saini,Grishma Kc,Adrian J Williams et al.
Mahima Saini et al.
The integration of artificial intelligence (AI) and machine learning (ML) into medical devices has revolutionized healthcare, enhancing diagnostic accuracy and clinical decision-making. However, their rapid evolution poses challenges to tra...
Drug Repurposing in Oncology: A Strategic Pathway to Unlocking New Therapeutic Potential [0.03%]
肿瘤学中的药物再定位：解锁新的治疗潜力的战略途径
Rahaman Shaik,Sai Geethika Laddika,Madiha Unnisa et al.
Rahaman Shaik et al.
The growing number of cancer cases and deaths highlights the urgent need for innovative treatment approaches. One technique that has lately been recognized as having potential to improve the existing cancer immunotherapy treatment is drug r...
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018-2025) [0.03%]
制药品中的亚硝胺污染：美国食品药品监督管理局召回的法规回顾性分析及风险缓解策略（2018-2025）
Sravani Yerram,V P Muhammad Nizam,Saurabh Srivastava et al.
Sravani Yerram et al.
Background: Product recalls play a critical role in pharmacovigilance, safeguarding public health under modern regulatory frameworks. Since 2018, the detection of carcinogenic nitrosamine impurities especially those excee...
Praveen J Samy,Morgane C Mouslim,Charles L Bennett et al.
Praveen J Samy et al.
Background: In 2019, the US Food and Drug Administration (FDA) finalized guidance for designating interchangeable biosimilars requiring pre-approval phase III clinical trials to evaluate safety when reference and biosimil...
Improving the Analysis of KCCQ Endpoints in Heart Failure Clinical Trials [0.03%]
改善心力衰竭临床试验中KCCQ终点的分析方法
Robin Myte,John Eriksson,Martin Rensfeldt et al.
Robin Myte et al.
Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is frequently used in heart failure (HF) clinical trials to evaluate treatment effects on function and symptoms. However, due to the 0-100 boundedness in KCC...
Physician Perceptions and Intentions in Response to Unsupportive Data for Off-label Uses: An Experimental Study with Primary Care Providers and Oncologists [0.03%]
关于医师对标签外用药的不支持数据的看法和应对意愿——一项针对初级保健医生和肿瘤学家的研究
Kathryn J Aikin,Simani M Price,Amie C O&#x;Donoghue et al.
Kathryn J Aikin et al.
Background: Physician awareness of evidence about off-label uses of prescription drugs can affect prescribing decisions. We tested approaches to disclosing unsupportive data about off-label uses and assessed disclosure im...
Navigating the Future: Considerations for use of Continuous Glucose Monitoring in Diabetes Trials [0.03%]
连续 glucose监测在糖尿病临床试验中的应用考量及未来展望
Anna Kettermann,Gauri Dandi,Jennifer Clark et al.
Anna Kettermann et al.
Background: A continuous glucose monitoring system (CGM) is a digital health technology (DHT) device that measures interstitial glucose. CGMs are used in the management of diabetes. The purpose of this study was to retros...
Patient Insights into and Satisfaction with Treatment, Management, and Clinical Research of Hereditary Hemochromatosis [0.03%]
遗传性血色病的治疗、管理和临床研究的患者见解和满意度
Sonya Abraham,Soraya Benchikh El Fegoun,Matthieu Marty et al.
Sonya Abraham et al.
Introduction: Hereditary hemochromatosis (HH) is a metabolic disorder characterized by excessive iron absorption, leading to damage of the liver, heart, and pancreas. The patient experience of living with HH has not been ...
Sales Erosion of Originator Drugs Following Generic Entry: Quantitative Analysis and Predictive Modeling [0.03%]
仿制药上市后原研药销量下降情况的量化分析与预测模型研究
Soon Kyu Jung,Sang-Won Lee
Soon Kyu Jung
Introduction: Generic drug entry into the pharmaceutical market typically leads to a substantial decline in originator sales. Understanding the extent and trajectory of this erosion is essential for effective lifecycle ma...