Year: 2020
Type: Article
Title: The use of remdesivir outside of clinical trials during the COVID-19 pandemic
Author: Halimi, Vesa
Author: Daci, Armond
Author: Ridova, Nevenka
Author: Panovska Stavridis, Irina
Author: Stevanovic, Milena
Author: Filipche, Venko
Author: Dimovski, Aleksandar
Author: Grozdanova, Aleksandra
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.
Publisher: Informa UK Limited
Relation: Journal of pharmaceutical policy and practice
Identifier: oai:repository.ukim.mk:20.500.12188/30013
Identifier: 2052-3211
Identifier: http://hdl.handle.net/20.500.12188/30013Identifier: 10.1186/s40545-020-00258-8
Identifier: https://link.springer.com/content/pdf/10.1186/s40545-020-00258-8.pdfIdentifier: https://link.springer.com/article/10.1186/s40545-020-00258-8/fulltext.htmlIdentifier: https://link.springer.com/content/pdf/10.1186/s40545-020-00258-8.pdfIdentifier: 13
Identifier: 1
