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Tuesday, September 26
Tue, Sep 26, 1:15 PM - 2:30 PM
Lincoln 5
CMC Session: Statistical Considerations When Assessing Product Stability and/or Shelf Life

Stability Studies in the IVD Industry (300386)

*Jeff Budd, Beckman Coulter 

CLSI EP25-A has helped manufacturers of IVD products establish and monitor the aging of their reagents and the subsequent loss of assay performance since 2009. Methods of improving the robustness of various types of reagent studies will be discussed including the reduction of measurement variability from various factors. With EP25 in the process of being updated, likely future changes will be explored.