Zobrazeno 1 - 10 of 79 pro vyhledávání: '"Dianne Murphy"'
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Akademický článek
Enhancing Consistency of Maximal Responding in Behavior Description Interviews: An Exploration of Priming and Response Length
Autor: Allen Huffcutt, Satoris Howes, Dianne Murphy, Sara Murphy
Publikováno v: Personnel Assessment and Decisions, Vol 10, Iss 1 (2024)
In a Behavior Description Interview (BDI), candidates are asked to describe past experiences that demonstrate skills and abilities important for the position (Janz, 1982). A recent study by Huffcutt et al. (2020) found that only around half of partic
Externí odkaz: https://doaj.org/article/db6fe9dfb112448497863e3a2acd6f0d
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Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States
Autor: Jean Temeck, Dianne Murphy, Irmgard Eichler, Dobromir Penkov, Lynne Yao, Paolo Tomasi
Publikováno v: Therapeutic Innovation & Regulatory Science. 51:360-371
Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate harmonization and global development of pediatric medicines, it is important to understand the legislative requirements that
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc3c20d7ec7b0ecf8efc4d7ba72c0767
https://doi.org/10.1177/2168479017696265
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6
A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013
Autor: Jean Temeck, Gunter F. Egger, Gerold T. Wharton, Paolo Tomasi, M. Dianne Murphy, Suzanne Malli
Publikováno v: Therapeutic Innovation & Regulatory Science. 50:639-647
The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediat
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::335d5230704481026f6810ef906fa918
https://doi.org/10.1177/2168479016646809
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Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension
Autor: Dianne Murphy, Robert M. Nelson, Haihao Sun, William J. Rodriguez, Ronald L. Ariagno, Norman Stockbridge
Publikováno v: Journal of Perinatology. 36:1029-1033
To identify suitable end points and surrogates for pediatric pulmonary arterial hypertension (PAH) as the lack of developmentally appropriate end point and clinical trials contribute to the unmet medical need.Reviewed the efficacy end points and surr
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::85f6724d644eaf3ced7ba5b9a8c7eda3
https://doi.org/10.1038/jp.2016.103
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Pharmacology Review: The Role of Biomarkers and Surrogate End Points in Drug Development for Neonatal Pulmonary Arterial Hypertension
Autor: Dianne Murphy, Ronald L. Ariagno, Norman Stockbridge, Haihao Sun
Publikováno v: NeoReviews. 17:e87-e92
Pulmonary arterial hypertension (PAH) is a rare disease in newborns, infants, and children. It is associated with significant morbidity and mortality, but has limited treatment options. Except for inhaled nitric oxide, which is approved for persisten
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::6534052d42a8e7fa79509797152aa24d
https://doi.org/10.1542/neo.17-2-e87
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Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success
Autor: Ann W. McMahon, M. Isabel Tejero-Taldo, Debbie Avant, Scott K. Winiecki, Dianne Murphy
Publikováno v: Pharmacoepidemiology and Drug Safety. 25:602-605
Purpose To determine aspects of the design of pediatric registries that contribute to the success of registries conducted as a postmarketing study following approval of drugs or biological products by the US Food and Drug Administration. Methods Pedi
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e6345e0248ec7fe99e7e6effbad3e4bf
https://doi.org/10.1002/pds.3939
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FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007–2013
Autor: Amy Odegaard, Dianne Murphy, Judith U. Cope, Pamela Weinel, Geoffrey L. Rosenthal
Publikováno v: Pediatrics. 136:1125-1131
BACKGROUND AND OBJECTIVES: In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA’s Pediatric Advisory Committee (PAC). These safety reviews pla
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::76a2e8efc7ae71ce659bbbabe2168d61
https://doi.org/10.1542/peds.2015-0469
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