New drugs: evidence relating to their therapeutic value after introduction to the market.

Abstract

BACKGROUND Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. METHODS We retrospectively analyzed… (More)
DOI: 10.3238/arztebl.2012.0117

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Cite this paper

@article{Ujeyl2012NewDE, title={New drugs: evidence relating to their therapeutic value after introduction to the market.}, author={Mariam Ujeyl and Claudia Anna Barbara Schlegel and Siegbert Walter and Ursula M. Gundert-Remy}, journal={Deutsches Arzteblatt international}, year={2012}, volume={109 7}, pages={117-23} }