Statistical Considerations on Analytical Equivalence Assessment
Xiaoyu Dong, FDA  Youngsook Jeon, CDER, FDA  Meiyu Shen, CDER, FDA  *Yi Tsong, FDA 

Keywords: analytical, similar

There is considerable interest in assessing the equivalence and similarity in analytical and process aspects of the products. The equivalence and similarity assessment may be required in method transform of the same product, between products with minor changes or between two products. Some aspects of the applications are relatively new and lack of statistical standards. Setting the margins of the tests is also challenging. In this presentation, we will discuss and comment on the approaches proposed and reviewed recently in many aspects of the applications.