학술논문
The use of remdesivir outside of clinical trials during the COVID-19 pandemic.
Document Type
Academic Journal
Author
Halimi V; Faculty of Pharmacy, University Ss. Cyril and Methodius University, Skopje, North Macedonia.; Daci A; Department of Pharmacy, Faculty of Medicine, University of Prishtina, Prishtina, Kosovo.; Ridova N; University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius University, Skopje, North Macedonia.; Panovska-Stavridis I; University Clinic of Hematology, Medical Faculty, University Ss. Cyril and Methodius University, Skopje, North Macedonia.; Stevanovic M; University Clinic of Infection Diseases and Febrile Conditions, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.; Filipce V; University Clinic for Neurosurgery, Medical Faculty, University Ss. Cyril and Methodius, Skopje, North Macedonia.; Dimovski A; Faculty of Pharmacy, University Ss. Cyril and Methodius University, Skopje, North Macedonia.; Grozdanova A; Faculty of Pharmacy, University Ss. Cyril and Methodius University, Skopje, North Macedonia.
Source
Publisher: Informa UK Limited Country of Publication: England NLM ID: 101627192 Publication Model: eCollection Cited Medium: Print ISSN: 2052-3211 (Print) Linking ISSN: 20523211 NLM ISO Abbreviation: J Pharm Policy Pract Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
2052-3211
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.
Competing Interests: Competing interestsVesa Halimi, Armond Daci, Nevenka Ridova, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce, Aleksandar Dimovski, and Aleksandra Grozdanova declare that no competing interests exist.
(© The Author(s) 2020.)
Competing Interests: Competing interestsVesa Halimi, Armond Daci, Nevenka Ridova, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce, Aleksandar Dimovski, and Aleksandra Grozdanova declare that no competing interests exist.
(© The Author(s) 2020.)