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Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis
BACKGROUND: At the time of approval of a new medicine, there are few long-term data on the medicine's benefit–risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Public Library of Science
2013
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601954/ https://www.ncbi.nlm.nih.gov/pubmed/23526887 http://dx.doi.org/10.1371/journal.pmed.1001407 |