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New Drugs: Evidence Relating to Their Therapeutic Value After Introduction to the Market

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 cen...

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Detalles Bibliográficos
Main Authors: Ujeyl, Mariam, Schlegel, Claudia, Walter, Siegbert, Gundert-Remy, Ursula
Formato: Artigo
Idioma:Inglês
Publicado: Deutscher Arzte Verlag 2012
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Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC3301972/
https://ncbi.nlm.nih.gov/pubmed/22427788
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3238/arztebl.2012.0117
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