A comprehensive review on Phyto-MAP: A novel approach of drug discovery against Mycobacterium avium subspecies paratuberculosis using AYUSH heritage

Srivastava, Varsha; Navabharath, Manthena; Khan, Muzayyana; Samal, Monalisha; Parveen, Rabea; Singh, Shoor Vir; Ahmad, Sayeed

doi:10.1016/j.jep.2024.118482

Journal of Ethnopharmacology

2024

DOI: 10.1016/j.jep.2024.118482

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A comprehensive review on Phyto-MAP: A novel approach of drug discovery against Mycobacterium avium subspecies paratuberculosis using AYUSH heritage

Varsha Srivastava,

Manthena Navabharath,

Muzayyana Khan

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

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

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A comprehensive review on Phyto-MAP: A novel approach of drug discovery against Mycobacterium avium subspecies paratuberculosis using AYUSH heritage

Cited by 1 publication

References 96 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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