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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Bibliographic Details
Main Authors: Wilde, Joshua T., Springs, Stacy, Wolfrum, Jacqueline M., Levi, Retsef
Other Authors: Massachusetts Institute of Technology. Operations Research Center
Format: Article
Language:English
Published: Springer International Publishing 2023
Online Access:https://hdl.handle.net/1721.1/152928