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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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| Main Authors: | , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Deutscher Arzte Verlag
2012
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| Assuntos: | |
| Acesso em linha: | 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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