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Activity Number: 546
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #314927
Title: Interim Equivalence Test with Application in Drug Development
Author(s): Yansong Cheng*
Companies:
Keywords: equivalence test ; interim analysis ; conditional power
Abstract:

Equivalence test is widely used in drug development, e.g., to show if two drugs are similar in biosimilar trial; or to show if one assay method can be transferred from lab to GMS. Interim test of equivalence test provides the opportunity to monitor the on-going study. In this work, we investigate the operating characters of the interim test and provide the closed form calculation for conditional power, which is the probability of declaring significance at the end of the study conditional on the data at interim. Sample size adjustment based on interim result is discussed.


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