From Laboratory to Patient: The Evolving Path to Become a Medicine

Autor:	Ana Hidalgo-Simon
Jazyk:	angličtina
Rok vydání:	2019
Předmět:	advanced therapy regenerative medicine gene therapy somatic cell therapy tissue engineering medicine regulation regulatory agencies european medicines agency (ema) Biology (General) QH301-705.5
Zdroj:	Molecular Frontiers Journal, Vol 3, Iss 2, Pp 138-146 (2019)
Druh dokumentu:	article
ISSN:	2529-7325 2529-7333 25297325
DOI:	10.1142/S2529732519400121
Popis:	Gene editing and other laboratory developments promise to revolutionize treatment of many diseases that currently have no cure. The process to become a medicine is long and complex and requires many years. Regulation of medicines (permission to market a product and monitoring of its performance) is evolving to adapt to emerging new approaches in development. Current issues and new ideas needed to navigate the difficult waters from laboratory to patient are discussed here: novel approaches for narrow evidence base, earlier discussions of evidence with regulators, earlier planning for post-authorization requirements and better patient access.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/c4cb467c1fa74f6aa94f2bf1007ad674 Zobrazit plný text záznamu View record in DOAJ