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...

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Detalles Bibliográficos
Autores principales: Duijnhoven, Ruben G., Straus, Sabine M. J. M., Raine, June M., de Boer, Anthonius, Hoes, Arno W., De Bruin, Marie L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Research Article
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

Internet

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

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