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1-6 of 6 results for E5 guideline

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First published 2009-1

Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

Wen-Hua Kuo

Therapeutic Innovation & Regulatory Science

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First published 2006-12

Simplified Controlled Studies in New Regions for Safety Concern Arising from using Foreign Safety Data

Yeong-Liang Lin, Chien-Hua Wu, K. Arnold Chan

Therapeutic Innovation & Regulatory Science

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First published 2000-10

Statistical Approaches to Accepting Foreign Clinical Data

Norisuke Kawai, Masakazu Andoh, Tohru Uwoi [...]

Therapeutic Innovation & Regulatory Science

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First published 2009-5

An Overview of Bridging Study Evaluation in Taiwan

Li-Li Su, Herng-Der Chern, I-Lin Ryan Lee [...]

Therapeutic Innovation & Regulatory Science

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Review article

First published 2011-11

Ten-year Experience of the Evaluation of Ethnic Sensitivity Data

Chia-Ling Hsiao, Yeong-Liang Lin, Li-Feng Hsu [...]

Therapeutic Innovation & Regulatory Science

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First published 2009-5

Industry Efforts on Simultaneous Global Development

Jean-Louis Saillot, Mark Paxton

Therapeutic Innovation & Regulatory Science