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12. 39 Proceedings of the 1 Annuol Meeting OQ 1
13. CT CT 0 3D
14. OTC 5 3 53 1
15. 21 Proceedings of the 1 Annual Meeting za
16. az OTC OTC ee ON
17. 25 Proceedings of the 1 Annual Meeting S 4 3
18. 36 Proceedings of the 1 Annuol Meefing S 9 2 spinal instrumentation SI
19. User testing of PIL Patient information Leaflets 42 Proceedings of the 1 Annuol Mee
20. HXLPE
21. Bae P e
22. S 2 2 Public Relations PR
23. 2010 1 12 7 CN 7 5
24. 16 22 107 13 18 898
25. iPS iPS iPS
26. PMDA 1 http wwwJpmda eo jp operations notice 2007 file 0928010pdf 20 Proceed
27. IT Qi2
28. 6 21
29. Thomson Reuters Pharma 2010 Thomson Reuters Pharma Clinical Trials gov
30. 24 RMP S 7 4 2004 ICH E2E
31. P_a 2011
32. 6 EVAHEART 1991 2 1993
33. S 7 2 30 1980 2009 26 Therapeutic Risk Management TRMP Pharmacovigilance Plan PvP 2
34. OTC 58 50 Proceedings of the 1 Annual Meefing
35. 7 8 2010 8 4 10 4
36. ES iPS ES iPS ES iPS
37. FEM 3D FEM 3 Proceedings of the 1 Annual Meeting S_s 4
38. 2 61 5 20 1 2 4 59 96 7 17 85 0 DB a a EO NIDA
39. ES iPS
40. Ti 6AI 4V CoCrMo go A 7 KK A7 7 Ti6AlL4V 500 1000 MPa 300 900 MPa CoCr
41. 2 Proceedings of the 1 Annual Meeting S s s
42. S 4 2007
43. Pp O CREIL FDA 20 12 22 7 24 7
44. IEC ISO IEC TC62 2010 10 IT
45. iPS S 3 2 ESViPS
46. 10 21 KHD1018 6110 24 Proceedings of the 1 Annuol Meefing S4 1 FTH Fisrt in Human Study FTH
47. PMRs 15
48. 2 15 2 3 2 26 8 3 13 5 3 2
49. O 4 3 3 TR 18 1 19 TR
50. ICHM3 R2 41 P gt PMDA
51. 59 2010 12 2010 1 12 2011 1 2 101 88 100 129 120 146 115
52. Dl 33 Proceedings of the 1 Annual Meeting Sa OTC 2 NANA EL
53. ICHM3 R2 22 2 19 0219 4 FDA 2005 EMEA 2007 POC
54. 1 2 2 3
55. 13 CTD web
56. sz 16 6 6 5
57. 2 MS A De _ CT
58. GHTF Global Harmonization Task Force Essential Principles 1SO7EC
59. Guidelines for the Regulatory Assessment of Medicmal Products for Use in Selt Medication WHO Geneva 2000 Ss MIE ds 40 5 ee el
60. ICH 3Rs Omics
61. 2010 12 S
62. 22 23 2
63. 100 IABP 46 Proceedings of the 1 Annuol Meeting Os a PP
64. 2 3 4 1 Proceedings of the 1 Annual Meeting 9 3 1 9 30 11 15
65. SI 1 2 3 4 SI SI
66. 10 65 7 Proceedings of the 1 Annual Meeting S
67. 43 6 Proceedings of the 1 Annual Meeting QO GO CP 55940
68. 58 5 22 8 4 5 6 1 2011 8 160 0
69. CRC 2 7 1 1 2 1 3 3 4 2 1 989 115 117 CRC 7 4 2
70. Ss 4 OTC 2009 6 OTC OTC 1
71. 9 a4 iPS iPS iPS 7z vitro FDA zz zo 100
72. 1 52 1992 2 61 1993 3 4 Olson H et al Concordance of the toxicity of pharmaceuticals in humans and in animals Regul Toxicol Pharmacol 2000 32 56 67 Rl 1 a HH HH a 65 1994 S 4 4
73. 5 6 5 2 7 8
74. ICHE2E RMP 4 ICH E2E
75. OTC OTC 11 OTC 2009 a A OTC I 0 OTC 3 1 590 450 1 000 2
76. 44 Proceedings of the 1 Annuol Meeting Os JFE 4 1 3 R 0 1 3 Hz L N M P h 2
77. 3 N Asn24 38 83 1 O Ser126 165 MW 18 235 7 3 3 MonoCap C18 0
78. information intelligence OTC rm 35 7 Proceedings of the 1 Annual Meeting S 8 5 OTC World Health Organization WHO
79. 0 Pp 2
80. 40 19 4 1 21 9 30 500 79 67
81. S_s 4 1 1 CDER Center for Drug Evaluation and Research Advisory Committee Committee 2 Federal Food Drug and Cosmetic Act Citizen Petition 21 CFR 10 30 FDA petition FDA 180 Citizen Petition FDA 2 EMA 1 EMA European Medicines a Agency CHMP Committee for Medicinal Products for Human Use
82. Vioxx Rosiglitazone 1 2 Pioglitazone ICH E2E 2005 4 lt RMP 1CH E2E
83. 50 Proceedings of the 1 Annual Meefing PS
84. 58 58 12 251 4 1
85. S e 4 2 2
86. 2000 2003 2011 7
87. RMP Scientifc Review
88. Proceedings of the 1 Annual Meefing PMI R 10 14 30 17 30 Dr Vicki SeyfertLMargolis FDA invited Professor Hans Georg Eichler EMA invited
89. vztro in vitro 7z vztro zz vitro jz vitro 1
90. SI SI SI ADL 1911 Hibbs Albee
91. ES iPS ES iPS SOX17 HEX HNF4a ES iPS 23 Proceedings of the 1 Annual Meeting S 3 3 iPS GPS
92. PMI Proceedings of the 1 Annuol Meeting S a a
93. 2 9 5 PMI PMI I 2 2 1977 PMI
94. 38 39 40 2 3 41
95. Proceedings of the 1 Annual Meeting 9 30 11 15 102 O 8 JFE O 9 O 10 ISO 14155 2011 ISO TC 194 WG 4 O 11 O 12 O 13
96. PMDA FDA EMA 2010 6 180 wet 17 PMDA PMDA 2004 PMDA FDA EMA PMDA
97. S 9 3 1 2 1 2 2 2
98. 179 5 9 GCP 6 5 GMP 5 4 5 2010 16 10 2011 12 9
99. 1 2 33 111 1 to 2 3 5 34 2
100. TRMP RMP PvP 1 ICH E2E PvP PV gt
101. 1 1 9 SS 2 9 30 11 15 1 2 3 9 30 11 15 3 4 iPS iPS ES iPS
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103. 1 01 95 3000 02 1 1 5 5 01 01 1 1 5 9 1 1 5 1 01 01 1 1
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105. 1992 1994 Olson 20 13 22
106. 3 1 27 2 3 oo 1 ww 63 Proceedings of the 1 Annual Meeting 4 4 2 28 1 4
107. 47 6 Proceedings of the 1 Annual Meefing P 1 PMDA 2010 4 2010 PMDA PMDA PMDA
108. 63 70 146 6 1 14 2 2 32 2 3 57 4 4 50 6 5 52 5 6 129 3 7 229 2 61 Proceedings of the 1 Annual Meeting 8 246 3 250 3
109. PvP PvP 32 Proceedings of the 1 Annuol Meeting 9 7 3 RMP
110. 54 1 66 Proceedings of the 17 Annual Meefing to 2 gt Co 9 55 23 6 30 56 57
111. 4 15 16 00 3 4 OTC OTC OTC Wh 14 OTC OTC OTC 9 14 15 16 00 1 2
112. 90 7 83 2004 4 PMDA
113. 2002 2010 441 Zineh 55 rl SNP 22 Or 2004 2011 3 12 44 33 16 7 7 HIV 17 HCV 16 CYP2C19 14
114. iPS iPS iPS
115. 2 9 3 10 Proceedings of the 1 Annual Meeting OTC FDA EMA
116. CT X MRI 2 23 3 WG 24 PMI E PMI
117. 101 102 PMDA 6 12 15 14 00 1 2
118. 9 7 4 1 1 5 7 52 Proceedings of the 1 Annual Meefing Pe
119. 29 Proceedings of the 1 Annual Meeting S 8 3 IT 2010 3 EU MDD
120. EMEA 483439 2008 rev 1 CHMP CHMP Scientifc Advisory Grounp 2 public consultation 3 Mediator EMA 6 23 22 Proceedings of the 1 Ann
121. 1 2 3 6 1 2 3 2 3 4 5 6 5 6 2 47 48 2 7 49
122. 12 15 14 00 12 15 14 00 0 i 10 15 00 16 00 16 00 14 30 17 30 Proceedings of the 17 Annual Meeting 00 00 2 3 80 iPS 00 9 30 11 15 9 30 11 15 00 6 IE 00 gt lt I a En 12 15 14 00 OO EE 00 4 5 i 1 2 3 4 202 1 18 15 9 8 OTC 14 15 16 00 OTC 14 15 16 00 00 00 00 17 45 18 15 00 Proceedings of the 1 Annual Meeting
123. 4 a a a 2 2 2 2
124. iPS iPS 12 Proceedings of the 1 Annual Meefing 277 Vv Mi W 5 12 15 14 00 4 12 15 14 00 First In Man
125. Regulatory Science Integration of Innovation into Society 9 30 11 15 101 O 1 O 2 O 3 O 4 O 5 O 6 O 7
126. 1 1 7 12 29 5 100 100 3000 FAX 5 Mo
127. 1998 8 ICH 10 8 11 672 2005 7 2010 11 459
128. 3 2 50 3 2 51 3 2 52 5 17 8 53 2
129. 31 Proceedings of the 1 Annual Meeting 9 7 1 3000 20 CTD RMP
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131. Society for Regulatory Science of Medical Products 2 3 4 1 3 SR 4 5 5 2 6 1 2
132. 2009 30 Proceedings of the 1 Annual Meeting S e s
133. 11 45 12 45 15 00 16 00 16 00 Proceedings of the 1 Annual Meefing 101 8430 2 1 2 03 4212 2000 A8 J CITY TOKYO Ne 5 1b A8 1b 3 5 Proceedings of the 1 Annual Meeting 1 OS IO Oi I
134. 1 Proceedings of the 1 Annual Meefing 1 2 9 2 12 00 16 00 9 3 9 00 16 00 20 000 10 000 30 000 6 000 1 2 100 3 2 3 4 2011 9 2 18 15 19 45 2 16 00 5 3 5
135. EVAHEART Proceedings of the 1 Annual Meeting 72 7 1 8 1 OTC 2 15 14 00 3 4
136. O 14 11 45 12 45 103 P 1 P 2 P 3 FD amp C Act and 21 CFR FDA Draft Guidance Financial Disclosure by Clinical Investigator P 4 P 5 P 6 P 7 P 8
137. FTIH FIH TGN1412 FIH
138. EVAHEART 3 2 20 5000
139. 91 2 42 2 43 65 Proceedings of the 1 Annual Meeting 6 44 7 1 6 30 45 46
140. ISO 14155 2011 1 ICH GCP GHTF ISO GCP
141. a 50 59 Proceedings of the 1 Annual Meeting 2 a 2 4 50 60 Proceedings of the 17 Annual Meefing SR sk 1 1
142. OTC 60 5 9
143. Proceedings of the 1 Annual Meefing bl LL LL Lg LT TI LT HARNESS YHNSD AL ESN a Proceedings of the 1 Annual Meeting 201 1 9 2 1 2 3 101 102 103 13 030 13 3 1 2 0 2 15 15 5 3 16 00 16 15 16 15 1 00 2011 9 3 8 00 9 0 1 1 DD 9 30 11 15 9 30 11 15 a 1 904 580 11 9 30 11 15 8 8 LD 11 45 12 45 4 5 13 00 First in Man
144. S s 4 PMDA 16 4 PMDA 7 PMDA PMDA 16 4 256 23 4 642 21 3 2 25 751 23 4 20 21 100 22
145. 1970 4 RCP 1975 BrAPP 2 RCP IFAPP BrAPP 14
146. S 4 e GMP PEG PEG
147. PMDA CTD 459 66
148. 98 HFS Stage HER2 PD 1 98 HFS 71 Grade 1 37 Grade 2 31 Grade 3 3 HFS 27 2 HFS 3 HFS Grade 1 182 Grade 2 195 HFS 84 P lt 0 001 4 PD HFS 2 28 HFS 4 7 P 0 0085 5 PD HFS 4 50 HFS 5 17 P 0 0395 6 HFS HFS HFS
149. EVAHEART 2002 ISO10993 NUM MNO UM RA 2006 6 18 GCP 2003 METTIS 2 2007 3 2006 2010 MACS
150. IL RE RP 2 IV ND E MM METIS
151. 61 16 i http www info pmda go jp Zineh I et al The Pharmacogenomics Journal 4 6 2004 354 358 54 Proceedings of the 1 Annual Meefing Pp LC MS 13 PAT
152. OUR 1 J ER 2 WHO 6
153. 17 FDA 21 8 21 6 3 3000 FDA NDA
154. 35 2 3 4 3 5 2 266 1 268 278 284 278 1
155. GCP GMP 91 1 Proceedings of the 1 Annual Meeting P 7 Pfizer Inc Global DSRD
156. P 9 P 10 2 16 Proceedings of the 1 Annual Meefing P 11 P 12 P 13 LC MS P 14 11 30 12 00 202 7 45 18 15 202 Proceedings of the 1 Annual Meeting S 1 1
157. QOL OTC OTC Re OTC 7 34 Proceedings of the 1 Annuol Meeting S s 3 OTC Selfmedication WHO
158. osurf gcon OO ISO 14155 2011 10 ISO TC 194 WG 4 BUN NET
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161. 2 26 Proceedings of the 1 Annual Meeting S s 1 Pharmaceutical Medicine
162. 4 3 4 1 20 22 TLO TR 1
163. 5 1 130 1 0 00997 1 5 60 4 0 00312 1 01 459 0 000992 0 1 1 200 3 0 00113 5 1 130 1 0 1 459
164. PMDA 2010 12 PMDA 2004 4 PMDA PubMed FDA EMA 2004 2010 PMDA 224 25 199 724 151 573
165. APPI 2005 2008
166. GCCP ISO TC 194 WG 4 1996 2003 1 5 EU GCP CH GCP 2 SO 14155 2011 2011 2 1 GCP ISO 14155 2003 ISO 14155 2011 ICH GCF GHTF ISO GCP
167. 11 3 2 1 2 3 2 12 8 3 13 1
168. 13 00 18 30 13 30 16 00 H KH EC 16 15 18 00 18 15 1 9 45 9
169. HepaRG iPS iPS zz vitro iPS iPS iPS iPS
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171. 35 64 Proceedings of the 1 Annual Meefing 1 2 2 5 36 2 2 2 3 1 2 3 5
172. PC 9 15 10 8 4 1 CD 2 Y MC 1 103 1 2 90cm 210cm P 20cm 20cm 90cm 190cm 3 No 9 3 11 00 11 30
173. 2 4 28 1 5 28 1 6 EC jt Seo 37 3 3 4 2 3 2 4 2 3 1 4
174. 49 1 Proceedings of the 1 Annual Meeting FD amp C Act and 21 CFR FDA Draft Guidance Financial Disclosure by Clinical Investigator Federal Food Drug and Cosmetic Act FD amp C Act Code of Federal Regulations Title 21 CFR Regulatory Practice FD amp C Act FD amp C Act CFR 1960 FD amp C Act A 5 170 3 4 58 137
175. Science Technology Scientific Technology Science and Technology
176. ICR 20 25 g conditioned place preference CPP CP 55 940 6 24 CPP FR1O0 CP 55 940 CP 55 940 CP 55 940 9 THC NG108 15 CP 55 940 CPP CB1 AM251 CP 55 940 THC CP 47497 JWH 018 NG108 15 CP 55 940 CP
177. 2010 12 24 FDA EMA 1 1 9 2 3
178. 2005 9 E2E 2007 2007 EFDA E2E FDA Post Marketing Requirements PMRs EU 2012 7 E2E 3
179. 3 3 PDF 3 CT OA 510 00 4 6 I CT Se 38 0 ED
180. 2 24 CD 4 25 1 3 20 2 1 2 2 1 26 2 19 1 3 3 1 7
181. 2 2 6 62 Proceedings of the 1 Annual Meefing 3 1 2 1 2 3 17 18 19 20 2 21
182. PAT PAT PAT A LC MS DMEM 1 0 gg 1 6 1 LC MS
183. 7 8 9 203 10 201 9 2 12 00 20 00 9 3 9 00 18 00 Proceedings of the 1 Annual Meeting 1 101 102 1 2 PowerPoint Windows OS 8 25 srsm ofice imic orjp PC Macintosh
184. 2000 10 2009 CFR 5 2 2 137 CFR IND Investigational New Drug Application NDA New Drug Application S312 S314 GCP CFRS54 Financial Disclosure by Chnical Investigator 5 24 Draft Guidance
185. 46 44 42 14 IL 0 83 0 17 0 1 0 850 150 TI 45 821 134 115 639 246 TY TV
186. 90 23 60 SS PMDA FDA 20 2 3 PMDA 28 Proceedings of the 1 Annual Meeting S e 1
187. MedDRA Web O
188. 9 29 2 2 4 3 2 1 4 30 3 2 31 2 3 32
189. ee 0 2 2 1 0 w v BSA 4 10 LC MS gg g 1 1 PAT Pa
190. 1 53 Proceedings of the 1 Annual Meeting Pp 1 2001 2009 NME NME 215 22 102
191. 2003 2010 2 2003 2010 14 14 8 1 2
192. Draft NDA fnancial interest and agreements Pp a 1000 19 128 19
193. 1 14 15 3 2 1 2 10 1 3 6 16 2 3 3 2
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195. 10 14 NeuGc 3 11 14 14 O 1 10 14 2 11 14 12 Hex 3 10 14 55 1 Proceedings of the 1 Annual Meefing
196. 20 50 Oe GPSP 1 2 3
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198. gt gt gt 4 2 2 0TC 50 S57 Proceedings of the 1 Annual Meeting
199. 2010 10 Cardiovascular Disease 5779 Endocrine Tumor 4641 Neurological Disease Brain disease 3145 3 3 30 60 40 IL 20 50 Cardiovascular Disease TV TI 100 TL TL
200. ISO 14155 2011 45 6 Proceedings of the 1 Annual Meeting QO 1 3
201. 256 3 7 2 8 2 9 1 2 3 4 2 5 2 10
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204. INNER vol Supplement 2011 REGULAIORY SCIENCE OF MEDICAL PRODUCTS 1 2011 9 2 3 Society for Regulatory Science of Medical Products Proceedings of the 1 Annual Meefing 1 3 11 14 46 1 1987
205. OTC OTC 10 OTC OTC OTC OTC OTC OTC
206. OTC 90 3 10 2030 4 800 2600 2010 OTC OTC OTC OTC 2012 3 OTC OTC
207. 016 35 TEL 03 5312 1466 FAX 03 5361 7091 101 0046 2 7 3 5F TEL 03 5256 6380
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210. ings of the 1 Annual Meeting Ss
211. ting OO HFS DLT HFS HFS
212. ual Meeting Ss iPS 2011 1 6 31 33 53 13 14

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