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
2002/10/03
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
2002/10/03
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
2002/10/03
Dr.Iwasaki / 3rd K-H Symposium