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http://hdl.handle.net/20.500.12188/10825| DC Field | Value | Language |
|---|---|---|
| dc.contributor.author | Vesa Halimi | en_US |
| dc.contributor.author | Armond Daci | en_US |
| dc.contributor.author | Simona Stojanovska | en_US |
| dc.contributor.author | Irina Panovska-Stavridis | en_US |
| dc.contributor.author | Milena Stevanovikj | en_US |
| dc.contributor.author | Venko Filipce | en_US |
| dc.contributor.author | Grozdanova, Aleksandra | en_US |
| dc.date.accessioned | 2021-03-10T10:25:56Z | - |
| dc.date.available | 2021-03-10T10:25:56Z | - |
| dc.date.issued | 2020-05-16 | - |
| dc.identifier.citation | Halimi, V., Daci, A., Stojanovska, S. et al. Current regulatory approaches for accessing potential COVID-19 therapies. J Pharm Policy Pract 13, 16 (2020). https://doi.org/10.1186/s40545-020-00222-6 | en_US |
| dc.identifier.uri | http://hdl.handle.net/20.500.12188/10825 | - |
| dc.description.abstract | This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients. | en_US |
| dc.language.iso | en | en_US |
| dc.publisher | BMC Part of Springer Nature | en_US |
| dc.relation.ispartof | Journal of Pharmaceutical Policy and Practice | en_US |
| dc.subject | COVID-19 | en_US |
| dc.subject | regulatory EMA | en_US |
| dc.subject | FDA | en_US |
| dc.subject | clinical studies | en_US |
| dc.subject | compassionate use | en_US |
| dc.subject | clinical practice | en_US |
| dc.subject | off-label use | en_US |
| dc.subject | emergency use | en_US |
| dc.title | Current regulatory approaches for accessing potential COVID-19 therapies | en_US |
| dc.type | Article | en_US |
| dc.identifier.doi | https://doi.org/10.1186/s40545-020-00222-6 | - |
| item.grantfulltext | open | - |
| item.fulltext | With Fulltext | - |
| crisitem.author.dept | Faculty of Medicine | - |
| crisitem.author.dept | Faculty of Pharmacy | - |
| crisitem.author.dept | Faculty of Medicine | - |
| crisitem.author.dept | Faculty of Medicine | - |
| Appears in Collections: | Faculty of Medicine: Journal Articles | |
Files in This Item:
| File | Опис | Size | Format | |
|---|---|---|---|---|
| s40545-020-00222-6.pdf | 488.99 kB | Adobe PDF | View/Open |
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