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Clinical Data for JNDA based on Bridging

Clinical Data for JNDA based on Bridging. Japanese Data. Foreign Data. PK/PD data. PK/PD data. Trial to compare with bridging trial in Japan. Bridging trial. Phase II, III trials Long-term trials Special populations. Clinical Data for JNDA based on Bridging. Japanese Data. Foreign Data.

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Clinical Data for JNDA based on Bridging

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  1. Clinical Data for JNDA based on Bridging Japanese Data Foreign Data PK/PD data PK/PD data Trial to compare with bridging trial in Japan Bridging trial Phase II, III trials Long-term trials Special populations

  2. Clinical Data for JNDA based on Bridging Japanese Data Foreign Data T I M E PK/PD data PK/PD data Phase IIb Dosefinding Study Phase IIa, III trials Long-term trials Special populations Bridging trial JNDA

  3. Issues for Simultaneous Global Drug Development • Regulatory Issues: - CTN requirements • - Endpoint acceptability • - Power for study (Japan alone?) • Extrinsic Factors: - IRB requirements • -Investigator Caution • Logistics: - Regulatory/hospital lead time • Translation of documents • Large number of centers • Risk: - Delay to Western Program • Conduct of “unnecessary” work • Increased Cost

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