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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 - #306579
Title: Statistical and Related Issues of Global Drug Development: Experience in the PMDA Consultation Meetings
Author(s): Yuki Ando*+
Companies: Pharmaceuticals and Medical Devices Agency
Address: Shin Kasumigaseki Building, Tokyo, 100-0013, Japan
Keywords: global drug development ; multinational clinical trial
Abstract:

After the ICH-E5 guidance, "Guideline for Ethnic Factors in the Acceptability of Foreign Clinical Data," was issued, efficiency in Japanese new drug development was improved with utilization of clinical study data from other regions. Recently, Japanese pharmaceutical companies have planned to participate in multinational clinical trials for global simultaneous drug development. In this paper, statistical and related issues that arise in the Pharmaceuticals and Medical Devices Agency consultation meetings on multinational clinical trials will be discussed.

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