Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

CANCELLED - TL09: Design and Analysis of Method Comparability Studies (300623)

*Charles Cheung, FDA 

Keywords: CMC, bioassay, method comparison, assay transfer, statistics

Method comparison studies are commonly performed in assay transfer between laboratories and comparison between different versions of an assay. The usual interest of these studies is to determine if two methods can be used interchangeably. To evaluate if the methods are comparable, acceptance criteria based on various statistical measures and graphical summaries (e.g., Deming regression, Bland-Altman plots, agreement statistics) are often used. In this roundtable, we will discuss the use of these statistical tools and the problems frequently seen.