Sea buckthorn extract mitigates chronic obstructive pulmonary disease by suppression of ferroptosis via scavenging ROS and blocking p53/MAPK pathways

Liu, Lu; Wen, Tian; Xiao, Ying; Chen, Hongqing; Yang, Shan; Shen, Xiaofei

doi:10.1016/j.jep.2024.118726

Journal of Ethnopharmacology

2024

DOI: 10.1016/j.jep.2024.118726

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Sea buckthorn extract mitigates chronic obstructive pulmonary disease by suppression of ferroptosis via scavenging ROS and blocking p53/MAPK pathways

Lu Liu,

Tian Wen,

Ying Xiao

et al.

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From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments

Cao,

Quan,

Hou

2024

DDDT

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In recent years, patient-focused drug development (PFDD) has received widespread attention as a new paradigm in clinical trials. The PFDD emphasizes patients are partners in research projects, where patients can participate in research design, implementation, and outcome measurement, rather than just providing data. PFDD has shown great value in the research and development of pharmaceutical products, such as in accelerating the process of patient enrollment and improving the success rate of drug approval. Many countries and regions, including the United States, China, and Europe, have issued relevant regulatory policies and guidelines related to PFDD, covering study design, implementation, and risk–benefit assessment. The core of PFDD implementation is clinical outcome assessment (COA), of which patient-reported outcome (PRO) is most common. As far as the US Food and Drug Administration is concerned, there are numerous COA tools waiting for qualification, but currently all qualified are PROs. This review focuses on PRO and explores the key elements of PRO instruments’ development, application, and inclusion in regulatory decision-making.

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From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments

Cao,

Quan,

Hou

2024

DDDT

View full text Add to dashboard Cite

show abstract

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Sea buckthorn extract mitigates chronic obstructive pulmonary disease by suppression of ferroptosis via scavenging ROS and blocking p53/MAPK pathways

Cited by 1 publication

References 63 publications

From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments

From the Formation of Conceptual Framework to Regulatory Decision-Making: Considerations for the Developments of Patient-Reported Outcome Instruments

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