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.(1) (1) 1 11-0006 AIN457 TSD 11-0008

.(1) 1 (2011427 02-0013 2011517) Ro45-2317() (2011427 20115112011518 06-0010 denosumab(AMG162)(denosumab) ) (2011426) 06-1003 () (2011414 07-0004 (ADPKD)OPC-41061( 201152) ) HER2/ErbB2 07-0008 1 GW572016(ALTTO)() (2011513 2011525) 07-0013 B(DLBCL) LY317615(Enzastaurin) 2011 (201152 08-0002 BMS-562247(Apixaban) 530) MSD (2011428 08-0006 SCH530348TIMI(IC)() 20115112011520 ) 16 229IRB

08-0007

08-0010 08-0015

08-0017 08-0021 08-0022

08-0025

08-0026 08-0028 08-0029

08-0030

09-0003

09-0004

09-0007

09-0008

09-0009

(2011428 MSD 20115112011520 2011527) SCH530348(TRACER)() (2011517) S-1 (2011427 / 20115162011525 ) (2011427 BAY43-9006( 2011512) ) IDEC-C2B8( (2011517) ()) (2011428 MSD 20115102011518 ) (2011425 SKI-606( 2011512) )(bosutinib) (2011420 FTY720() 20114272011511 () ) MSD (2011525) MK-0683(FL)(vorinostat) (2011519) CDP870(MTX)( ) (2011519) CDP870() L-dopa (2011524) SPM962() (Rotigotine) 1 (2011420 20114262011427 20115620115 DU-176b(Edoxaban) 112011516) 1 (2011427 20115132011517 RO4368451(Pertuzumab) ) 1 ErbB-2 (2011517 2011525) Neratinib(HKI-272)() AZD1152() 1

26 229IRB

09-0011

09-0012

09-0013

09-0015 09-0016 09-0018

09-0022

09-0023

09-0024

09-0026

09-0029

09-0030

10-0001

10-0003

10-0004

10-0005 10-0006

36

(2011516) KW-6002()(istradefylline) (201159 2011 CMC-544(2001)(Inotuzumab Ozogamicin) 517) (2011427 RAD001()() 2011512) 1 () (2011510) ABI-007(SB) (2011511) (2011427 RAD001( 2011512) )() (2011517 2011525) HKI-272-3004(Neratinib) (2011422 /(ADHD) 20115112011520 LY139603()() ) (201159 2011 516) (2011427 JNJ26866138(MCL)( 2011516) ) (201159 2011 TRK-100STP(b/)( 592011513 2011513) ) 2011 (201159 520) Ro47-0203() (2011426 SyB L-0501(Agg) 201159 2011525 () ) (201156 2011 59) CC-5013() 1 OPC14597()() (2011516) 1 OPC14597()() (2011516) (2011428

229IRB

10-0008

10-0009

10-0010

10-0011

10-0014

10-0015

10-0016

10-0017

10-0018

10-0019

10-0020

10-0021

10-0022 10-0023 10-0024

AF37702()() 2011513) (2011422 2011427 201159 SyB L-0501(MM)() 201151720115 24) FSK0808 (2011428) 1 (2011418 2011523) AD-810N() (2011420 20114272011511 20115182011 56()201159 ()2011520( )) ( (2011425 ) 201159) SPD422() (2011427 2011513) (2011519) CDP870()(certolizumab pegol) PCI (2011527) CS-747S(ACS)(prasugrel) (2011511 2011525) (2011414 OPC41061()() 201152) (2011425 MSD SCH420814() 20115112011520 ) (2011427 / 20115162011525 JNS001 ) (2011427 / 20115162011525 JNS001() ) (2011524) KRN125 (2011519) KRN125(Pegfilgrastim)

46 229IRB

11-0001 11-0004

(2011513 2011517) RO5304020(Marianne) (2011527)

2) (2011421) H09-0001 Ba679 BR Respimat (2) 1) 07-9002 TRE-956() 09-9003 AVJ-09-385() 10-9001 ()( ) NK938( 10-9003 )

1 (2011421) (2011523 2011523) (2011516)

.(1) (1) 1) 06-0010 denosumab(AMG162)(denosumab) [TEMP03/4 07-0004 (ADPKD)OPC-41061( (2)](2011120) ) MSD SCH530348-06(2011422) 08-0005 SCH530348TIMI(IN)() MSD SCH530348-06(2011422) 08-0006 SCH530348TIMI(IC)() // MSD SCH530348-06(2011422) 08-0007 SCH530348(TRACER)() /Global Investigator's Brochure for S-1 version2.0(20114 08-0010 S-1 22) 77(2011428 08-0022 MSD )

56 229IRB

08-0028 09-0003 09-0004 09-0011

MSD MK-0683(FL)(vorinostat) L-dopa SPM962() (Rotigotine) DU-176b(Edoxaban) KW-6002()(istradefylline)

77(2011428 ) Ver.13.0(2011428) 11(2011425)

09-0013

09-0018

09-0023

09-0026

10-0007 10-0011 10-0014 10-0020 11-0002 11-0004

/(RAD001) 9(20101214)/ RAD001()() Ver.4(2011510)/( ) /(RAD001) 9(20101214)/ RAD001( Ver.4(2011510)/ )() () /(ADHD) LY139603()() Version7.0(20112 JNJ26866138(MCL)( 28) ) ENG-J / ( ) SPD422() MSD SCH420814()

(2) 1) // 10-9001 ()( ) JJ-CRD05 10-9002 () NK938( 10-9003 )

66 229IRB

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