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Summary of Discussion

Summary of Discussion. Summary of Discussion. Issues Practical use of ICH E5 guideline Simultaneous global drug development. Practical use of ICH E5 guideline. Bridging strategies – two issues Clinical aspects: Intrinsic factors Genomic information – individual variability

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Summary of Discussion

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  1. Summary of Discussion

  2. Summary of Discussion • Issues • Practical use of ICH E5 guideline • Simultaneous global drug development

  3. Practical use of ICH E5 guideline • Bridging strategies – two issues • Clinical aspects: • Intrinsic factors • Genomic information – individual variability • Extrinsic factors: • Medical practice – impact on therapeutic effects

  4. Practical use of ICH E5 guideline • Bridging strategies – two issues • Design aspects: • Statistical issues – under investigation • Def.of similarity, sample size ??? • Design aspects: • Double blind placebo control ???

  5. Simultaneous global drug development • Global development strategies – two issues • Scientific based evidence: • Surrogate markers • Dose response, individual variation (PK/PD) • Quick and objective measurement, unvalidated • Genomic information • Design issue – selection of target population by pharmacogenomics approach

  6. Simultaneous global drug development • Global development strategies – two issues • Regulatory dialogue: • Asian collaboration • APEC meetings in Taipei, 2001, and Tokyo 2002 • Asian countries can be considered as one region • Evaluation and review systems • Transparent drug development strategies and review system between regulatory bodies and sponsors , ex. Merge of KIKO and PMDEC

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