Development and Application of a Data-Driven Signal Detection Method for Surveillance of Adverse Event Variability Across Manufacturing Lots of Biologics
Abstract Introduction Postmarketing drug safety surveillance research has focused on the product-patient interaction as the primary source of variability in clinical outcomes. However, the inherent complexity of pharmaceutical manufacturing and distr...
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Format: | Article |
Language: | English |
Published: |
Springer International Publishing
2023
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Online Access: | https://hdl.handle.net/1721.1/152928 |