ｽﾗｲﾄﾞﾀｲﾄﾙなし

Personal Perspective on Bridging
Domestic Data
Foreign Data
PMS
Pivotal
dose-response
IIa
PK / PD
“Bridge” is one of many bridges in the
development of a new drug.
It is not bigger, but rather smaller.
Non-Clinical
0
Clinical
I
IIa
IIb
III
Dose
PD parameter
Clinical endpoint
PK parameter
Analysis of Dissimilarity
Dose
PK parameter
Clinical endpoint
PD parameter
 Clinical endpoint
 Dose
=
 Clinical endpoint
 PD
.
 PD
 PK
.
 PK
 Dose
Bridging in Baseball
Batting Average
0.400
0.380
0.360
0.340
0.320
0.300
Japan
U.S.
0.280
0.260
0.240
0.220
0.200
Shinjo Ichiro
Shinjo
Ichiro

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