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Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.12188/10825
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dc.contributor.authorVesa Halimien_US
dc.contributor.authorArmond Dacien_US
dc.contributor.authorSimona Stojanovskaen_US
dc.contributor.authorIrina Panovska-Stavridisen_US
dc.contributor.authorStevanovikj, Milenaen_US
dc.contributor.authorVenko Filipceen_US
dc.contributor.authorGrozdanova, Aleksandraen_US
dc.date.accessioned2021-03-10T10:25:56Z-
dc.date.available2021-03-10T10:25:56Z-
dc.date.issued2020-05-16-
dc.identifier.citationHalimi, 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/s40545-020-00222-6en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12188/10825-
dc.description.abstractThis 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.isoenen_US
dc.publisherBMC Part of Springer Natureen_US
dc.relation.ispartofJournal of Pharmaceutical Policy and Practiceen_US
dc.subjectCOVID-19en_US
dc.subjectregulatory EMAen_US
dc.subjectFDAen_US
dc.subjectclinical studiesen_US
dc.subjectcompassionate useen_US
dc.subjectclinical practiceen_US
dc.subjectoff-label useen_US
dc.subjectemergency useen_US
dc.titleCurrent regulatory approaches for accessing potential COVID-19 therapiesen_US
dc.typeArticleen_US
dc.identifier.doihttps://doi.org/10.1186/s40545-020-00222-6-
item.grantfulltextopen-
item.fulltextWith Fulltext-
crisitem.author.deptFaculty of Medicine-
crisitem.author.deptFaculty of Pharmacy-
crisitem.author.deptFaculty of Medicine-
crisitem.author.deptFaculty of Medicine-
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