A new approach to psychiatric drug approval in Europe.

Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new produ...

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Autores principales:	Corrado Barbui, Irene Bighelli
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/b8e696bbe06c4bc6a133b42fe091c518
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spelling	oai:doaj.org-article:b8e696bbe06c4bc6a133b42fe091c5182021-11-18T05:43:07ZA new approach to psychiatric drug approval in Europe.1549-12771549-167610.1371/journal.pmed.1001530https://doaj.org/article/b8e696bbe06c4bc6a133b42fe091c5182013-10-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24143137/?tool=EBIhttps://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.Corrado BarbuiIrene BighelliPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 10, Iss 10, p e1001530 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Corrado Barbui Irene Bighelli A new approach to psychiatric drug approval in Europe.
description	Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.
format	article
author	Corrado Barbui Irene Bighelli
author_facet	Corrado Barbui Irene Bighelli
author_sort	Corrado Barbui
title	A new approach to psychiatric drug approval in Europe.
title_short	A new approach to psychiatric drug approval in Europe.
title_full	A new approach to psychiatric drug approval in Europe.
title_fullStr	A new approach to psychiatric drug approval in Europe.
title_full_unstemmed	A new approach to psychiatric drug approval in Europe.
title_sort	new approach to psychiatric drug approval in europe.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/b8e696bbe06c4bc6a133b42fe091c518
work_keys_str_mv	AT corradobarbui anewapproachtopsychiatricdrugapprovalineurope AT irenebighelli anewapproachtopsychiatricdrugapprovalineurope AT corradobarbui newapproachtopsychiatricdrugapprovalineurope AT irenebighelli newapproachtopsychiatricdrugapprovalineurope
_version_	1718424811208704000

A new approach to psychiatric drug approval in Europe.

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