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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2015
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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 |