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Drug safety assessment in clinical trials: methodological challenges and opportunities

Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patient...

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Detalles Bibliográficos
Autores principales: Singh, Sonal, Loke, Yoon K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3502602/
https://www.ncbi.nlm.nih.gov/pubmed/22906139
http://dx.doi.org/10.1186/1745-6215-13-138