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.

A New Approach to Psychiatric Drug Approval in Europe

BARBUI, Corrado;Bighelli, Irene
2013-01-01

Abstract

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.
2013
psychiatry; drug approval
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/632952
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