VOL.28, Suppl ‡]‡X 2001@@ƒuƒŠƒbƒWƒ“ƒOEƒXƒgƒ‰ƒeƒW[
Bridging Strategies
@ @
–Ϊ ŽŸ
 
˜@•ΆStephen W.Lagakos
’|“ΰ³O
iii
 
Faculty Members iv-v
 
Program vi-vii
 
Opening Remarks and Welcoming Address²“‘“oŽu˜Y1
 Delcan P.Doogan3-4
 
Global HarmonizationChaired:James H.Ware@ 5-28
 
@ Global Harmonization and Achievements of ICHElain C.Esber7-16
 
@ Impact of ICH Process and Guidelinesγ“cŒc“ρ17-23
 
@ Discussion 25-8
 
Ethnic DifferencesChaired: –ξθ‹`—Y29-88
 
@ Drug Metabolism  
@@ Interethnic Differences in Drug MetabolismΞθ‚Žu31-51
 
@ Disease Presentation West vs East  
@@ Cardiovascular Disease in Asia: Mortality and Risk Factors@ Jiang He53-63
 
@ Dose Setting  
@@ Significance of Dose Setting Studies in the Bridging Study Strategy@  “ΰ“‘ŽόK65-76
 
@ Discussion  
@@ Discussant Speech‘ΊθŒυ–M77-9
@@ Discussant Speech‹g–μ ‰p81-3
@@ Panel Discussion 85-8
 
Bridging StrategiesChaired: ˆδ‘Ί—T•v89-165
 
@ Bridging: Efficacy and Safetyμ‡αΑˆκ91-103
 
@ Bridging: Methods and Special Populations  
@@ The Challenge of BridgingJames H.Ware105-21
 
@ Bridging: Statistical Considerations (1)  
@@ Statistical Issues on Bridging Studies’|“ΰ³O123-30
 
@ Bridging: Statistical Considerations (2)  
@@ Methodological Issues in Evaluation of Bridging Evidence
@@ @for Pharmaceutical Products
Jen-Pei Liu131-42
 
@ Bridging Guidance•½ŽR‰ΐL143-51
 
@ Summary and Panel Discussion  
@@ Discussant Speech“ΰŽR–ΎD153-4
@@ Summary and Panel Discussion 155-65
 
Future Strategies and ChallengesChaired: Nan M.Laird167-206
 
@ Bridging Western Data to Japanβˆδ•Ά•F169-74
 
@ Bridging Japanese Data to West  
@@ Bridging Studies: Characterization of A Drug's Sensitivity
@@ @to Ethnic Factors
Richard Pazdur175-8
 
@ Depression: Western and Japanese Differenceγ“‡‘—˜179-88
 
@ Discussion  
@@ Discussant Speech“‘Œ΄NO189-95
@@ Discussant Speech“‡’JŽ‹`197-9
@@ Panel Discussion 201-6
 
Summary and ConclusionStephen W.Lagakos209-16
 ’|“ΰ³O217-9


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