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Activity Number: 97
Type: Topic Contributed
Date/Time: Monday, August 7, 2006 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract - #306231
Title: Design and Analysis for Showing the Similarity of Drug Efficacy between Two Clinical Studies
Author(s): Yoshiharu Horie*+ and Hajime Uno and Masahiro Takeuchi
Companies: Nippon Boehringer Ingelheim Co., Ltd. and Kitasato University and Kitasato University
Address: , Hyogo, , Japan
Keywords: proportion of similar response ; similarity ; bridging study
Abstract:

One of the challenging issues regarding "bridging study," defined in the ICH E5 guideline in new drug developments, is to evaluate the similarity of treatment effects between an original region and the other new region. The proportion of similar response (PSR) is a measure to quantify the overlap of two density functions of continuous random variables, which gives a direct interpretation of the similarity between those two random variables. Therefore, the PSR approach is appropriate for this purpose. We illustrate this applied to actual data.

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