Marketing authorisation of orphan medicines in Europe from 2000 to 2013 Article Swipe
Matthias P. Hofer
,
Hanna Hedman
,
Maria Mavris
,
Franz Koenig
,
Thorsten Vetter
,
Martin Posch
,
Spiros Vamvakas
,
Jan Regnström
,
Stiina Aarum
·
YOU?
·
· 2017
· Open Access
·
· DOI: https://doi.org/10.1016/j.drudis.2017.10.012
YOU?
·
· 2017
· Open Access
·
· DOI: https://doi.org/10.1016/j.drudis.2017.10.012
An analysis was performed on a data set of 157 orphan designated medicines with an outcome for marketing authorisation application (MAA) between 2000 and 2013. The intention was to understand the factors associated with marketing authorisation success, the challenges developers face regarding orphan medicine development, and how scientific advice (SA) is used during development. The results demonstrated that orphan medicines have a lower success rate compared with non-orphan medicines and that determinants for marketing authorisation success were company size and compliance with SA. Compliance with SA could help orphan medicine developers overcome clinical development challenges.
Related Topics
Concepts
Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.drudis.2017.10.012
- OA Status
- hybrid
- Cited By
- 31
- References
- 17
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2766543377
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W2766543377Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1016/j.drudis.2017.10.012Digital Object Identifier
- Title
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Marketing authorisation of orphan medicines in Europe from 2000 to 2013Work title
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reviewOpenAlex work type
- Language
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enPrimary language
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2017Year of publication
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2017-10-23Full publication date if available
- Authors
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Matthias P. Hofer, Hanna Hedman, Maria Mavris, Franz Koenig, Thorsten Vetter, Martin Posch, Spiros Vamvakas, Jan Regnström, Stiina AarumList of authors in order
- Landing page
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https://doi.org/10.1016/j.drudis.2017.10.012Publisher landing page
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://doi.org/10.1016/j.drudis.2017.10.012Direct OA link when available
- Concepts
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Orphan drug, Authorization, Marketing authorization, Business, Marketing, Medicine, Bioinformatics, Computer science, Computer security, BiologyTop concepts (fields/topics) attached by OpenAlex
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31Total citation count in OpenAlex
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2025: 3, 2024: 5, 2023: 3, 2022: 2, 2021: 3Per-year citation counts (last 5 years)
- References (count)
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17Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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