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...

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Bibliographic Details
Main Authors:	Katia Bruxvoort, Lina S. Sy, Bradley K. Ackerson, Jeff Slezak, Lei Qian, William Towner, Kristi Reynolds, Zendi Solano, Cheryl M. Carlson, Steven J. Jacobsen
Format:	Article
Language:	English
Published:	Elsevier 2021-08-01
Series:	Vaccine: X
Subjects:	Hepatitis B vaccine Vaccine safety Post-licensure studies Post-marketing requirement Real-world evidence
Online Access:	http://www.sciencedirect.com/science/article/pii/S2590136221000188

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http://www.sciencedirect.com/science/article/pii/S2590136221000188

Challenges in Phase 4 post-licensure safety studies using real world data in the United States: Hepatitis B vaccine example

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