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http://hdl.handle.net/20.500.12188/30013
Title: | The use of remdesivir outside of clinical trials during the COVID-19 pandemic | Authors: | Halimi, Vesa Daci, Armond Ridova, Nevenka Panovska Stavridis, Irina Stevanovic, Milena Filipche, Venko Dimovski, Aleksandar Grozdanova, Aleksandra |
Issue Date: | 2020 | Publisher: | Informa UK Limited | Journal: | Journal of pharmaceutical policy and practice | Abstract: | With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols. | URI: | http://hdl.handle.net/20.500.12188/30013 | ISSN: | 2052-3211 | DOI: | 10.1186/s40545-020-00258-8 |
Appears in Collections: | Faculty of Medicine: Journal Articles |
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