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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC