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Advanced and Global Drug Development Techniques: Brigding Strategies and Pharmacogenomics

Advanced and Global Drug Development Techniques: Brigding Strategies and Pharmacogenomics. Simltaneous/ Worldwide Development Strategies: Overview. Thomas K ue rner, M.D. Nippon Boehringer Ingelheim Co., Ltd. Key success factor for bridging.

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Advanced and Global Drug Development Techniques: Brigding Strategies and Pharmacogenomics

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  1. Advanced and Global Drug Development Techniques: Brigding Strategies and Pharmacogenomics Simltaneous/ Worldwide Development Strategies: Overview Thomas Kuerner, M.D. Nippon Boehringer Ingelheim Co., Ltd.

  2. Key success factor for bridging • Clarify influence of extrinsic and intrinsic factors • Careful analysis of PK/PD in different populations • Confirmation of dose-response relationship in different ethnic groups • Confirmation of safety profile in submitted region The 3rd Kitasato-Harvard Symposium

  3. Example from Asian Trials in mild to moderate essential hypertension using ARB The 3rd Kitasato-Harvard Symposium

  4. Conclusions Past • Little experiences among regulatory agencies with Asian multi-center trials • Mostly retrospective bridging strategies applied by the sponsors Future • Prospective Asian collaborative registration trials • Ensuring of compliance to ICH agreed standards • Competitive enrollment will enhance performance in different Asian countries The 3rd Kitasato-Harvard Symposium

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