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- W2324389756 abstract "After notification of ICH-E5 guideline, the number of “bridging studies” has been increasing. By September 2002, 7 new chemical entities, for which a new drug application data package included data from a bridging study, have been approved by MHLW. Recently simultaneous global clinical development has been becoming more popular than bridging strategy for the development of new chemical entities in the world. Such a trend forces Japanese to join the worldwide clinical development and also to conduct single protocol multi-international sites studies. We have two experiences of one-protocol two international sites studies since 2001. From those experiences, three important points have been revealed in order to achieve a successful international clinical study: 1) To establish and to maintain a robust communication line, 2) To build reliability among study sites through the communication line, and 3) To prepare and to conduct the study by considering the clinical and cultural background of each individual study region." @default.
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- W2324389756 date "2003-01-01" @default.
- W2324389756 modified "2023-09-30" @default.
- W2324389756 title "Points to Consider for Multinational Clinical Pharmacological Study Based on the Experience of One Protocol Two International Sites Study" @default.
- W2324389756 doi "https://doi.org/10.3999/jscpt.34.3_91" @default.
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