Off-label prescription: Practice and problems

Approval of a drug for clinical use requires production of data on efficacy and safety through submission of results from randomized controlled trials (RCTs), in which the new molecule is usually compared with placebo (or an active comparator) for a set of outcomes that will serve as the basis for t...

Full description

Bibliographic Details
Main Authors: António Vaz Carneiro, João Costa
Format: Article
Language:English
Published: Elsevier 2013-09-01
Series:Revista Portuguesa de Cardiologia (English Edition)
Online Access:http://www.sciencedirect.com/science/article/pii/S2174204913001803