Subject: COVID-19
Subject: clinical practice
Subject: clinical trials
Subject: compassionate use
Subject: conditional approval
Subject: early access scheme
Subject: emergency use
Subject: expanded access
Subject: remdesivir
Year: 2020
Type: Article
Title: The use of remdesivir outside of clinical trials during the COVID-19 pandemic
Author: Vesa Halimi
Author: Armond Daci
Author: Nevenka Ridova
Author: Irina Panovska-Stavridis
Author: Stevanovikj, Milena
Author: Venko Filipce
Author: Aleksandar Dimovski
Author: Aleksandra Grozdanova
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: BMC Part of Springer Nature
Relation: Journal of Pharmaceutical Policy and Practice
Identifier: oai:repository.ukim.mk:20.500.12188/10860
Identifier: Halimi V, Daci A, Ridova N, Panovska-Stavridis I, Stevanovic M, Filipce V, Dimovski A, Grozdanova A. The use of remdesivir outside of clinical trials during the COVID-19 pandemic. J Pharm Policy Pract. 2020 Sep 21;13:61. doi: 10.1186/s40545-020-00258-8. PMID: 32968487; PMCID: PMC7503054.
Identifier: http://hdl.handle.net/20.500.12188/10860Identifier: https://doi.org/10.1186/s40545-020-00258-8
