Current regulatory approaches for accessing potential COVID-19 therapies

Autor:	Vesa Halimi, Armond Daci, Simona Stojanovska, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce, Aleksandra Grozdanova
Jazyk:	angličtina
Rok vydání:	2020
Předmět:	covid-19 regulatory ema fda clinical studies compassionate use clinical practice off-label use emergency use Therapeutics. Pharmacology RM1-950 Pharmacy and materia medica RS1-441
Zdroj:	Journal of Pharmaceutical Policy and Practice, Vol 13, Iss 1 (2020)
Druh dokumentu:	article
ISSN:	2052-3211
DOI:	10.1186/s40545-020-00222-6
Popis:	This 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.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/fc1fbfad4b8f4e3fb0b3944f76ab9822 Zobrazit plný text záznamu View record in DOAJ Plný text ve formátu PDF Plný text ve formátu HTML
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