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Specialist Cohort Event Monitoring Studies: A New Study Method for Risk Management in Pharmacovigilance

The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for ‘real-world’ post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pa...

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Detalles Bibliográficos
Autores principales: Layton, Deborah, Shakir, Saad A. W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4328122/
https://www.ncbi.nlm.nih.gov/pubmed/25564333
http://dx.doi.org/10.1007/s40264-014-0260-x