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Clinical Development Process in ICH E5 Environment (1)

Clinical Development Process in ICH E5 Environment (1). Current status ; Classical bridging Bridging study in PIIb (DFS) Aiming skipping PIII Most efficient in legacy products Only acceptable on prospective planning Need to reduce the initial GAP for simultaneous filing.

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Clinical Development Process in ICH E5 Environment (1)

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  1. Clinical Development Process in ICH E5 Environment (1) • Current status ; Classical bridging • Bridging study in PIIb (DFS) • Aiming skipping PIII • Most efficient in legacy products • Only acceptable on prospective planning • Need to reduce the initial GAP for simultaneous filing Dr.Iwasaki / 3rd K-H Symposium

  2. Clinical Development Process in ICH E5 Environment (2) • Current Target ; From Bridging to Global Study • P.I ; one site study / one protocol with two sites • PIIa ; Pharmacological bridging • Participation in Global studies for simultaneous filing 1, Conditions for starting PI 2, Validity of surrogate marker in PIIa 3, Integrated Global development plan with Japan input 4, Regional modification of the study protocol 5, Sample size - Only from Japan, or from Asian region Dr.Iwasaki / 3rd K-H Symposium

  3. Clinical Development Process in ICH E5 Environment (3) • Future Target ; Global Drug Development • Core data from pivotal global studies • Regional studies for all sites • Simultaneous filing with same documents • Regional adjustment of labeling • Need to consider Integrated Global Review Dr.Iwasaki / 3rd K-H Symposium

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