Výsledky vyhledávání - "Bjørn Larsen"

Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

Autor: Scott W. Roberts, Tara Laura Brandt Elvang, Laila Syed, Marianne Bork Samuelsen, Eva Lisby Arp-Hansen, Henrik Kim Nielsen, Ida Katrine Lund, Dorte Lunøe Dünweber, Nicolai Listov-Saabye, Dorte Bjørn-Larsen, Anette Hjelmsmark, Tue Anker Mikkelsen

Publikováno v: Therapeutic Innovation & Regulatory Science. 57:386-395

The U.S. Food and Drug Administration and European Commission have developed successful orphan drug legislation to promote the research, development, and marketing approval of drugs to treat rare diseases. Central to these regulations are the concept

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::601a230e678cbe7698a92bd51ade07d2
https://doi.org/10.1007/s43441-022-00477-y

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Akademický článek

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Emergent premises in student experiences of a first-year electrical engineering course

Autor: Lars Lundheim, Torstein Bolstad, Thomas Tybell, Bjørn Larsen, Patric Wallin

Publikováno v: European Journal of Engineering Education

This study explores how project-based learning in combination with other pedagogical scaffolding approaches influences students’ experiences during their transition into the university. Based on the thematic analysis of interviews with students at

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c5695a3c6c1c19b0c05676433196cc64
https://doi.org/10.1080/03043797.2020.1789069

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Share Economy Jurisdiction

Autor: Torsten Bjørn Larsen

Publikováno v: Larsen, T B 2022, Share Economy Jurisdiction . in C R Hamer, H V G Pedersen & N J Clausen (eds), Festskrift til Bent Ole Gram Mortensen . Djøf Forlag, pp. 289-302 .
University of Southern Denmark

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::129e670386211459dd5282e31fda098b
https://portal.findresearcher.sdu.dk/da/publications/484d6080-1036-48c0-b67f-3e0377616be3

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IP-beskyttelse af sportsudstyr

Autor: Torsten Bjørn Larsen

Publikováno v: Larsen, T B 2021, IP-beskyttelse af sportsudstyr . i B Liin, H H Edlund, S Karstoft & T Iversen (red), Festskrift til Palle Bo Madsen . 1. udg, Djøf Forlag, s. 557-568 .
University of Southern Denmark

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::4a597a17a91102cc8cb063fc1902709c
https://portal.findresearcher.sdu.dk/da/publications/e3717d15-877c-4ccb-894a-9aa108399706

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Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.

Autor: Roberts, Scott W.¹ (AUTHOR) osrb@novonordisk.com, Elvang, Tara Laura Brandt¹ (AUTHOR), Syed, Laila¹ (AUTHOR), Samuelsen, Marianne Bork¹ (AUTHOR), Arp-Hansen, Eva Lisby¹ (AUTHOR), Nielsen, Henrik Kim¹ (AUTHOR), Lund, Ida Katrine¹ (AUTHOR), Dünweber, Dorte Lunøe¹ (AUTHOR), Listov-Saabye, Nicolai¹ (AUTHOR), Bjørn-Larsen, Dorte¹ (AUTHOR), Hjelmsmark, Anette¹ (AUTHOR), Mikkelsen, Tue Anker¹ (AUTHOR)

Publikováno v: Therapeutic Innovation & Regulatory Science. Mar2023, Vol. 57 Issue 2, p396-398. 3p.

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