Dr. Mike Ferris Clinical Data for JNDA based on Bridging Japanese Data PK/PD data Bridging trial Foreign Data PK/PD data Trial to compare with bridging.

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

Dr. Mike Ferris Clinical Data for JNDA based on Bridging Japanese Data PK/PD data Bridging trial Foreign Data PK/PD data Phase IIb Dosefinding Study Phase IIa, III trials Long-term trials Special populations TIMETIME JNDA

Dr. Mike Ferris 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