Comparison of Different Analysis Approaches to Analytical Method Transfe
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Yi Tsong, FDA  *Jinglin Zhong, FDA 

Keywords: Assay transfer, equivalence

Analytical method transfer is an important part of analytical method development and maintenance. The current common practice of analytical method transfer is based on the equivalence of the means between the development laboratory and the production laboratory. However the most scientific sound approach would show the equivalency of individual sample readings between the two laboratories.

In this talk, analysis approaches to address individual equivalence between laboratories will be discussed. These approaches will be compared with each other and also with the mean equivalence approach. Examples will be presented to illustrate each analysis approach and also the comparisons.