VOL.28, Suppl �]�X 2001　　Bridging Strategies

contents
Bridging Strategies
Extrapolating Clinical Data to New Regions for Drug Development
Preface	Lagakos S / Takeuchi M	iii
Faculty Members		iv-v
Program		vi-vii
Opening Remarks and Welcoming Address	Sato T	1
	Doogan D	3-4
Global Harmonization	Chaired: Ware J	5-28
Global Harmonization and Achievements of ICH	Esber E	7-16
Impact of ICH Process and Guidelines	Ueda K	17-23
Discussion		25-8
Ethnic Differences	Chaired: Yazaki Y	29-88
Drug Metabolism
Interethnic Differences in Drug Metabolism	Ishizaki T	31-51
Disease Presentation West vs East
Cardiovascular Disease in Asia: Mortality and Risk Factors	He J	53-63
Dose Setting
Significance of Dose Setting Studies in the Bridging Study Strategy	Naito C	65-76
Discussion
Discussant Speech	Murasaki M	77-9
Discussant Speech	Yoshino H	81-3
Panel Discussion		85-8
Bridging Strategies	Chaired: Imura H	89-165
Bridging: Efficacy and Safety	Kawai S	91-103
Bridging: Methods and Special Populations
The Challenge of Bridging	Ware J	105-21
Bridging: Statistical Considerations (1)
Statistical Issues on Bridging Studies	Takeuchi M	123-30
Bridging: Statistical Considerations (2)
Methodological Issues in Evaluation of Bridging Evidence 　　 　for Pharmaceutical Products	Liu J	131-42
Bridging Guidance	Hirayama Y	143-51
Summary and Panel Discussion
Discussant Speech	Uchiyama A	153-4
Summary and Panel Discussion		155-65
Future Strategies and Challenges	Chaired: Laird NM	167-206
Bridging Western Data to Japan	Sakai F	169-74
Bridging Japanese Data to West
Bridging Studies: Characterization of A Drug's Sensitivity 　　 　to Ethnic Factors	Pazdur R	175-8
Depression: Western and Japanese Difference	Kamijima K	179-88
Discussion
Discussant Speech	Fujiwara Y	189-95
Discussant Speech	Shimatani K	197-9
Panel Discussion		201-6
Summary and Conclusion	Lagakos S	209-16
	Takeuchi M	217-9

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