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Challenges in Phase 4 post-licensure safety studies using real world data in the United States: Hepatitis B vaccine example
Post-licensure vaccine safety studies are essential to identify adverse events that may not have been detected in pre-licensure clinical trials and to address questions that arose during the pre-licensure phase. These studies are increasingly conducted using real-world data collected as part of rout...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8233154/ https://www.ncbi.nlm.nih.gov/pubmed/34195599 http://dx.doi.org/10.1016/j.jvacx.2021.100101 |