Format, Content, Review, Approval, and
Contents
1.2.
3.
4.
5. 2
6. e
7. Y
8. Pf 25 V 2 2 6
9. GVP GPSP
10. 11
11. IX 3 3
12. DD DA
13. 26 3 31 http www pmda go jp guide jyohokokai kohyo file 1 7keikaku3 pdf 0331 44
14. V 2 2 5 1
15. 1 2 4 1 OOOO OO OOOO3 OOOO
16. E 3
17. mi i 1
18. 1 NN 2 3 4
19. RMP 76 J RMP Ri
20. RMP 94 F y 3 3
21. 1 2 1 2
22. V 3 1 3 1 2
23. 1 1 gt In
24. 1 IX 3 2 4 o
25. CTD module 1 8 Aggregate Data Aggregate Data
26. X I 82
27. 0 ICH E2B RMP
28. Y 2
29. 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 IM NMM B 0
30. 2 3 88 RMP JRMP 1
31. E J i ICHE2E p LRMP 7 E2CR2 3 16 1 P FTEHRITE
32. R 1 25 12 25 Q amp A 3 Q amp A1
33. RMP 107 0411 2
34. V 2 2 4 1 2 Cm
35. 6 X 1 Y 1 6 4 20XX X
36. ub 67
37. sy gt a 77 4 2
38. JJ RMP rv 26 8 H RMP
39. 7 I RMP Risk Management Plan 2
40. e PSURs 148 25 PMS 1 E9
41. ke 1 26 3 31 http www info pmda so jp Kkyoten_iyaku file db_kiban_bunseki_guide pdf 2 JPMA News Letter 2014 1 No 159 40
42. 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 r 47 A4
43. 2 rms BE Wh E
44. J RMP HH
45. 0 MO 00 6 400 OO hi RMP 24 9 7 Q amp A Q amp A13 126 VIII 2 J RMP M1 11 5 7
46. 142 H
47. ll V 2 2 8 1
48. 25 12 25 Q amp A 3 Q amp AS VIII 8 2 25 12 20 1220 14
49. http www pmda go p operations anzen info bunsyosoudan html 26 3 2 132 FAX 03 3506 9441 B 3 lt gt 1
50. RMP V 1 1
51. Meiji Seika 25 4 26 4
52. Par a
53. 6 2 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 120 6 2 6 3
54. RMP 24 7 3 40 45
55. AL i 33
56. w E E 3
57. gt gt gt 32 V 3 2 3
58. STUDY m 9 AN 3 9 x bp NN o
59. mechanistic safety studies Large simple clinical trials IX 3 2
60. 140 CSRs ul IX 3 1
61. GVP GPSP AM i BP
62. 8 RMP J RMP 3
63. O FE 1 MD and Barton Covert MD Michael J Klepper 0 f 31
64. V 3 paiiiil J RMP aii V 3 1 V 3 1 1 Ej
65. ai VI 5 RMP ICH E2E 9 DH Ot o
66. IX 3 1 2 IX 3 1 3
67. X 81
68. MHRA 8 IX 3 4
69. k DD side effect adverse drug reaction 24 12 28 1228 7 25 4 4 0404 4 FDA 21 CFR part 312 IND safety reporting reduirement 2010 9 2011 9
70. emg msg ee 113 VII 11 5 5 1
71. g 3 135 25 3 6 Q amp A 2
72. RMP 5 P26 28 1
73. 1 2 1 3 4 JE 5 1 2 3 4 mt
74. 1 1 8
75. 150 RMP 26 8 26 8 1 PMS 4 HH 3 4 1 103 0023 TEL 03 3241 0326 FAX 03 3242 1767
76. E 1 RMP 12
77. RMP 1 0 ml H RMP
78. 2 4
79. E E
80. Y
81. 24 4 11 0411 1 25 3 6 Q amp A 2 Q amp Al1 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 2014 1 3 31 19 21
82. RMP V 2 2 7 1
83. 0 24 7 3 3 44 24 7 3 4 77 4 2
84. 1
85. 2 x DB x 2 DB gt gt OR 0 nae a i EE Solici
86. AL E Research question 3 1 2
87. Research question Step3 Research question STUDY V 4 1 Step3 STUDY STUDY STUDY
88. DB 1 RS E Data Validaton ul J 3 gt b 55
89. 80 2 gt 77 4 2 80 2 273 RMP 2 ss SS IV J RMP IV 1
90. 24 9 7 Q amp A Q amp A3 25 12 25 Q amp A 3 Q amp A3 123 7 1
91. O
92. 2012 JRMP 2005 9 H 4 3 J RMP I eS i 4 1 J RMP 6 RMP 7
93. ul Oo OO OO RMP j RMP
94. 2 KJ Tn RECIST 1 2 3
95. I
96. 172005 E9 ICH E2E CTD module 1 11 1ICHE2E ICH E2E
97. 86 VII 7 2 E E E E EE 87 i i Wa O 1 gt
98. E f 1 2
99. 25 3 6 Q amp A 2 Q amp AS RMP J RMP RRR 48 VII 3 RMP
100. 1 1
101. 2 3 79 1
102. J RMP CTD CTD 13 EE RMP 4 3 1 12M 8Y NIR iti F
103. V 2 2 2 1 1 1 1
104. 2 84 xX
105. 0 Po IX 3 2 3 OA 60 X X 1
106. 30 5 ao J 6 ee 5 gt gt
107. fF CTD1 8 7 2 SD 124
108. SN 1 2014 19 1 57 273 16 3 30 0330001
109. Aggregate Data Aggregate Data Aggregate Data Aggregate Data 2
110. CTD 1 11 8 i a 25 3 6 Q amp A 2 Q amp A9 VIII 2 2
111. 25 12 20 1220 14 138 IX IX 1 http www info pmda do jp rmp to_company html 139 IX 2 24 7 3 ICH E2E 17 9 16 0916001 0916001 DEVELOPMENT SAFETY UPDATE REPORT E2F Step4 version ICH E2F 4 2010 August 17 PBRER ICH E2C R2 4 2012 December 17 Practical Aspects of Signal Detection in Pharmacovigilance Report of CIOMS Working Group VIII Guideline on GVP EU GVP A
112. 13 eee tL 9 4 25 607 77 VII
113. ga J RMP JRMP J RMP T RMP J RMP a RMP lI 2 J RMP
114. 73 VII 7 1 1 a
115. RMP 19 13 8 2 2 0 1 PMS 2 2014 4 P47 51 VII 10 2 1 108 I
116. 1 2 3 1 NG 2 3 85
117. CPK FDA Guidance for Industry Drug Induced Liver Injury Premarketing Clinical Evaluation Hy s Law case 2011 TF3 HE
118. SS 75 2 3 6 Q amp A 2 Q amp A3 4 MedDRA J PT SMOQ SOC _ I
119. I 3
120. 5 2 3 114
121. 1 2 MR 1 5 DD
122. VII 10 1 52 24 4 11 0411 1 0411 2 Mi VII 10 2
123. 6 j XR
124. 3 4 J RMP RO
125. 1 1 VIII 4 J RMP hh E
126. j E l 2
127. 1 G e 2 G e 3 ie 1 24 2 2013 3 2 105 110 3 2009 46 81 8
128. 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 VII 8 2 1
129. 2014 3 VII J RMP VII 1 RMP
130. 17 3 31 0331015 24 9 7 Q amp A Q amp A12 VII 2 1
131. 38 y oe 2 2006 9 PMS 4 PMS STUDY STUDY oO O x x o O 6 RE ADR Em Ah O O x x
132. Research question 52 Step3 Research question STUDY Step Step2 i ps V 4 1 Step3 STUDY STUDY STUDY STUDY 1 STUD
133. 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1
134. Aggregate Data E E 2
135. GPSP en V 4 1 FF
136. RMP kl k 134 VIII 6 J RMP 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1
137. PS performance status 12 29 1 4 1 2 3 4 V 3 2 V 3 2 1 AeGREGATE DATA 1 Aggregate Data
138. 110 1 1 HMS
139. 30 Aggregate Data a Ne H 1 1 Vv VV VV _ Y VV VV YY Aggregate Data
140. GPSP GPSP GCP DB er ee i e 5 I 20 i 0 i mee 5 244 F
141. Aggsregate Data RR DSUR J RMP RMP 2012 4 E 2
142. E Agsregate Data Aggregate Data rechallenge positive NNN 2 9N 2 dechallenge positive RN
143. 1
144. 2 EA CE 2 2 OR 2 HH 2 B 1 2 2 3 mn
145. RMP IV 1 1 1 2 Aggregate Data 3
146. 1 2 3 4 5 ml 6 1H EUGVP Module XVI 42 FE VI
147. 2 8 26
148. 1 2 5 2 3 4 5
149. E 7 E 3 3 2 rl H
150. 6 51 VII 4 E H 1 J RMP gt Research Queston 2
151. WHO UMC IX 3 3 2 e f 9 146 e e 2 WHO UMC IX 3 3 3
152. 9 _ 13 _RMP_ 3 136 Dt 12345678_21000AMY00123_RMP_001 pdf 13 RMP_001 2 001
153. Suspected Adverse Reaction CRE Sec 312 32 IND safety reporting c 1 IND safety reports GG Serious and unexpected suspected adverse reaction The sponsor must report any suspected adverse reaction that is both serious and unexpected The sponsor must report an adVerse event as a suspected adverse reaction only if there is evidence to suggest a causal relationship between the drug and the adverse event such as V 3 3 V 3 3 1 1 2 34
154. 1 1 1
155. 1 H 2
156. 63 3 DB 1 5 http www mhlw so jp stf shingi 0000050197 html PMDA PMDA P21 3
157. A B i ms tt C D LRMP 2
158. RMP J RMP J RMP J RMP J RMP 3 45 VI 6 J RMP OS CE
159. 1 J RMP 2 J RMP ee
160. 3 GCP E Data DB STUDY GCP
161. a 57
162. 17 EE mi TF RMP 7 ER 2 V 1 2
163. 56 Ei X
164. 5 EU RMP REMS RMP J RMP EU RMP REMS PV J RMP 2 J RMP
165. STUDY 1 4 1 B i AA 6 1 24 2
166. GPSP GCP STUDY DB RMP 3 DB DB
167. Id 1 LRMP 24
168. 91 1 2 2 H 2 2
169. DB a DB H DB DB GCP Pa a GCP STUDY 1
170. RMP k l Aggregate Data Aggregate Data V3 2 1
171. I 1 0 2 2 2 13 586 363 GPSE
172. Fr IR 0 lt 2 LRMP 24 9 7 Q amp A Q amp A1 5 6 25 3 6 Q amp A 2 Q amp AG
173. 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 J RMP E 1 Nt
174. II 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 E gt 2 5
175. MedDRA J SMQ PT e CH E e 0 xX IL XX MedDRA J SOC
176. 2 PROS CONS 1 2 PROS CONS A Y
177. MedDRA SMQ QT 147 Ch 0 IX 3 5
178. 2 ROO NT 1 2 61 1 PROS CONS A
179. EU GVP Annex I Definitions Risk management system RMP 24 4 11 0411 1 0411 2 F 24 4 26 0426 2 0426 1 EU RMP EU J RMP REMS US Risk Evaluation and Mitigation Strategy
180. x O O x o o EE IN amp x 2 x O O
181. 1 EH Er NE gt Er 1 6 Step1 Step 1 Step2 Research question
182. IV 2 IV 2 1 IV 2 2
183. oO o o o X O O 8 1 O o x o x a x O O O x 2 QO O 2
184. j f 1 1 PBRER 46 RMP 4
185. Hy 24 2012 4 J RMP 25 2013 4 1 RMP ICH E2E
186. E 109 4 6 2
187. gt gt gt gt gt gt gt gt
188. 74 0 24 4 26 0426 2 0426
189. 25 3 6 Q amp A 2 Q amp AS8 H E 131 HH 24 9 7
190. 5 83 Ts
191. 21 V 2 2 9 1 pill 9 G V 2 2 1 1
192. 97 4 2 2 4 3 E
193. VI 3 ICH E2E g IM 3 iR 43 3 1 RMP VI 4 I OT
194. gt 143 Qr TT IX 3 2 1 1 1 IX 3 2 2
195. 95 9 28 19 RMP
196. Q 111 0 O
197. H Step4 V 4 1 Step4 D No 2 http yww mhlw so jp shingi 2006 10 dl s1019 Sb pdf DB DB Validation
198. K gt CIOMS VI 3 1 gt Agsregate Data 1 DSUR V 3 2 2 1
199. NO Ny o a ee e e
200. 6 0 k 105
201. E 3 2 HH a 106 F
202. 1 O GPSP
203. 8 EE P 2 I 1 E i
204. 3 Phase Ila Proof of concept Pivotal study Aggregate Data 1 DSUR RR OS
205. Aggregate Data Phase IIa Proof of concept Pivotal study Aggregate Data Aggregate Data E
206. 27 V 2 2 9 1
207. 58 H 2 NII GO T Step1 Step2 Research question
208. STUDY 1 1 B 1 1 24 2
209. 2 Research question STUDY H A B A B D A B C D 59 Step4 STUDY V 4 1 Step4 STUDY
210. Aggregate Data V 3 2 1 Aggregate Data Agsgregate Data Aggregate Data 28 CRF CRF Phase
211. x 4 PMS PMS 1 PMS 2003 Sept 8 1 1 2 Step4 Step3 STUDY ec 586 STUDY STUDY il 13 lt
212. 2 4 2 117 E 2 4 6 1 G
213. GPSP GPSP GCP DB GPSP GPSP GCP DB 54 STUDY Step4 V 4 1 Step4 1 GPSP GCP DB 1
214. X MedDRA J SMQ PT 1
215. 6 18 10 19 18 1 No 2 http yww mhlw so jp shingi 2006 10 dl s1019 Sb pdf 39 e 1
216. 3 1 2 3 130 H 4
217. STUDY GPSP GPSP GCP DB GPSP GCP DB 1 60 STUDY GPSP GCP 1 18 10 19 18 1
218. 6 X TL xXx MedDRA J SOC PT 0
219. STUDY PVP 36 PROS CONS NN StepS Research question STUDY 1 e 2
220. CRF 4 EDC Electronic Data Capture CRE CRF EDC CRF V 3 1 2 1 V 3 2 2
221. CCSI V 3 3 2 35 V 4
222. RAD AR 18 9 Step5 PROS CONS Research question a i
223. 1 C 1 J x Rls 16
224. PT X e
225. wy 25 12 26 6 MID NET 26 7 1 WEB http www mhlw so jp st7houdou 0000049773 html RMP 28
226. fr 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 1 1 2 1
227. 1 1 1 2 2 89 2 0 3 2 1 1 2 3 ER 3 1 2 3 3 1 A 1 2 2 3
228. 1 2 3 DSUR
229. 2 1 1 2 3 4 5
230. 25 12 25 Q amp A 3 Q amp A4 24 4 26 2 24 9 7 Q amp A Q amp AS 0426 2 0426 1 1 1 2 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 128
231. IV 2 1 kk 15 IV 2 2 IV 2 3 ii 16 We OASISede8eeaistdekeest 17 V 1 i 17 V 1 1 SE 0 17 V 1 2 SI 29 AE 0 18 V 1 3 SUCRRSSSSERRERSSSBR2 SHSSRS0258SRE SRRCNSS5EGHSGHRESSSSSRK 19 V 2 TRMP 20 V 2 1 21 V 2 2 kk 22 V 3 kk 28 AS 2 28 V 3 2 ED 30 WW 4 00 NN 34 V4 kt 36 V 4 1 EKGHICAD y PR 36 V 5
232. LE J RMP E E E RMP E
233. 1 1 1 Phase Ila Proof of concept Pivotal study Aggregate Data 2 3 Aggregate Data Y Aggregate Data
234. RMP DB IJ RMP DB 26 6 P16 EARN A 64
235. 4 141 H 4 WHO Vigibase FDA AERS 40 2
236. 25 12 25 Q amp A 3 Q amp A4 VIII 3 J RMP gt a ul 13 5 gt 1 1 11 6 21 899 2 11 E mo 25 4 3 1 ie EE
237. Q amp A Q amp AS 26 4 1 anzen2 menkai pmda go jp anzen1 menkai pmda go jp
238. 26 6 http vww mhlw so jp st houdou 0000049773 html 65 VII 5 Xm Hn 5 HL 66 24 4 26 0426 2
239. uimaa lt a 75 VII 7 2 VIL 8 kk 93 VIL 8 1 SR Ek 94 VII 8 2 kk 94 VII9 101 VIL 10 104 WO 2 2 AIR SNRSRSRGGSs 105 VIL10 2 RIE 105 VIL1I1 114 VIL 12 119 V21 PP 122 VE 3 4 2 126 HHHU J RMP kk 126 VII 2 J RMP ML 127 VIII 2 1
240. 23 FE 1 V 2 2 3 1 2 Phase
241. e IX 3 1 1
242. VIII 2 3 2 25 3 6 Q amp A 2 Q amp A10 1 1 127 MW HI GCP
243. EE Aggregate Data 1 Aggregate Data QT Ns IV 1 2
244. E mri 15 IV 2 3 GVP GxP G
245. 1 121 VII 13 7 122 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1
246. RMP 26 8 1 2 26 8 PMS 1 4 gt 1 56680080508080388358503d3333558588e25as3s388258 le EERE EGE EE EE ei 3 II aaaaacauauauuuuuuuuuuuuuuauauaauuuuuusuuueeseeeeeeeeeeeeeeeee cece 4 4 J RMP kk 6 3 kk 8 IV J RMP AaNaEaeeesiereaehEeaeNesssaa 11 TV 1 kk 11 IV 1 1 kk 11 IV 1 2 J RMP kk 12 IV 2
247. 1 1 5 000 EO 9 GVP GP sp EM ii o o 1 ie 3 MR o Oo a MA Gpsp c eo
248. 65 496 S96 1 a 20 500 48 600 EE RNN 62 StepS PROS CONS gt
249. 5 ul 24 9 7 Q amp A Q amp A11 VIII 2 1
250. gt 2 gt SmPC gt PSUR RMP SmPC
251. 2 22 1 1
252. VII 7 1 3 E er RMP E RMP 78
253. 2 A C 1 3 2 1 1 1 2 3 5 5 1 5 2 1 J RMP A 1 1 B 1 1 1 2 aa 1 2 2 2 C
254. 9 F EC gt gt Meiji Seika ML
255. O O O EE O O 1 QO O O QO O O QO O QO O QO O QO Es O a QO QO O O O 1
256. f 1 Tl SS Hf r IM Ca 3 E F f j
257. un in RMP f k RMP rmp pmda go jp CD R DVD R SE ul lt RMP 137 3 25 3 4 0304 1 0304 1 VIII 8 VIII 8 1
258. y 9 5 90 3 C 1 2 2 3 3 a i 3
259. 0426 1 25 3 4 0304 1 0304 1 M1 11 ul 87 O
260. 100 VII 9 3 101 ks 24 4 26 0426 2 0426 1 25 3 4
261. PBRER 25 5 17 0517 1 29 19 V 2 J RMP etc
262. lt gt 1 2 3 133 lt gt gt 1 2 J RMP 1 1 2 4 5 1 5 3 RMP
263. J RMP RMP ENV 0 OO 5 0 lf 00
264. RMP 3 VIL3 VIL11 J RMP Y Y Y
265. 2 1 E Q 3 Research ON E B STUDY 2 Er F
266. J RMP PMS 242012 10 J RMP er nul Cd JT RMP RMP RMP RMP
267. Step1 V 1 Step2 Research question Research question Research question Research question 7 Step3 STUDY Step4 STUDY STUDY RAD AR 2006 9 17 9 16 0916001 0916001
268. GHope 2013 3 15 2 RAD AR 18 9 http www rad ar or 1p pharmacoepidemiology guideline index html 3 17 9 16 0916001 0916001 Step3 Step4 Step3 STUDY STUDY RAD AR 37
269. 8 IFL gt gt gt gt Contract Research Organization CRO 4 HH 1 E
270. GLe CTCAE e 95 e e e NNH Numbers Needed to Harm 1 1 et al 2014 19 1 37 VII 7 1 1
271. gt 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 Ny J RMP 68 1 Hy 8 ll
272. ME gt e 0 IL 2 92 VII 8 2
273. ck 1 RMP_002 25 3 4 0304 1 0304 1 VII 7 4 1 1 2 9 8 9 5 6 BH RS lt od o 3MB 3MB
274. 2 6 3
275. 25 3 4 0304 1 0304 1 VIII 7 3 1 OOO OO OO T 2 3 PDF
276. 26 PMS 1 MSD
277. SSNS 127 VIII 2 2 kk 127 VIII2 3 i 127 VII 3 J RMP 128 VI MB 129 VS 38M 3 130 VI 6 JRMP 135 WI 2 RNN 136 VIII 7 1 RS26ce SNR 03 SR SSC 136 VIIZ2 i 136 VIII 98 AEINIA2A EAA020 Se 136 VIIL 7 4 kk 137 VIIL89 SS 138 VIII 8 1 138 VIII 8 2 uri 138 oe 139 61x AGSNSANNSSR0 ROBESRESS 32 GHCSKSGG 8 139 10 140 IX 3 CIOMSVI EU GurpELrNE MODULE IX Lk 140 8 Rd 141 I S82 Sk A kk 143 IX 3 3 ki 145 I 84 SS 147 IX 3 5 kk 148
278. kk 42 VI RMP 43 5 jcRIMPO 2300000000008282025508825832256525255882523252522e2oass5336c3553948ee3so35 VI 1 43 VI 2 kk 43 VI 2 1 ae 43 VI 2 2 1 VI 3 VI4 VIS kk 45 VL6 ANAN EE 46 WI FRMP SRE6 6 47 VIL1 SN 47 VIIL 2 VI 3 VII 4 VII S NR 66 VIL6 Sk Sk lt ER 71 VIL7 SNE 74 VIL 7 1
279. mi go SO CTD MI 8 7 8 2 ENE 0 0 0 2 KAHLEOEMRHE CIENR KO TE 7 7
280. OOOO 87 1 RETF FLEEMNE TITS 20 69 2 ll OOOOO HI 87 OB 87 87oooo O
281. RMP 7 Wz ea 18 V 1 3 2
282. 0 25 12 25 Q amp A 3 Q amp A2 24 4 26 0426 2 0426 1 25 3 4 0304 1 0304 1 o
283. 103 VII 10 4 104 NN GE 24 4 11 0411 1 0411 2
284. J RMP 1 11 THRMP CTD module 20 V 2 1 ai
285. 0304 1 0304 1 FF 2 2 102 RMP 1
286. 145 E Oo 1 2 E IX 3 3 1
287. 3 2 7 125 VIII VIII 1 J RMP
288. 93 ICHE2E RMP VII 8 1 RMP VII 8 2 ICH E2E Ia tk
289. B C D A B C D A B D A B D 53 Step4 STUDY Step Step3 STUDY V 4 1 Step4 STUDY STUDY
290. Y 115 RMP 24 9 7 Q amp A
291. Y 8 Y 49 Q O QO QO O 6
292. 2 2 ke 2 fe 1 2 3 4 1 X 2 3
293. 1 6 EE 6 118 VII 12 Cw a HF J ul 119 k
294. 9 7 Q amp A Q amp A10 0 LRMP 129 VIII 5 J RMP
295. Q amp A2 8 4 7 VIII 7 J RMP VIII 7 1 1 2 4 1 ul bak 2 25 4 3 1 2 25 3 4 0304 1 0304 1 sg VIII 7 2 1 5 3
296. Research question ON 3 DB vs day Data validation DBOYI RMIP PVP 2 1 1 7 NPO
297. 1 25 3 4 0304 1 0304 1 CTD CTD M2 5 6 2 J RMP VII 7 1
298. J RMP VI 1 pl 3 EE 3 e CCDS PSUR PBRER Global Core RMP EU RMP REMS VI 2 VI 2 1 TIX 3 VI 2 2
299. RAD AR 18 9 1 1 65 65 WW Rw G00 g 2 2 1 65 7 cs 2509 et 2som mr 20 500 0 S06 2 2 let EE 65 96 496 zow soy
300. Q amp A2 116 5 5 1 I 6 8 6 8 4 6
301. 00000 00000 00000 20 ABC ABC ABC DEF 25mg 1 20mL DEF400mg DEF Sms 70 VII 6 71 E a
302. 1 a 21 3 9 25 H 4 4 1 RR n e Fr 1 NN
303. 144 1 NN OA 38 IT
304. 46 http mol medicalonlne jp newsletter m86ubn0000000210 at 2014 159 18 pdf 3 14 6 17 2 4 1 http www mhlw go jp stf seisakunitsuite bunya hokabunya kenkyujigyou i kenkyu index html 4 RAD AR 18 9 http www rad ar or jp pharmacoepidemiology guidehne index html 96 2 3
305. 7 1 2 E
306. ICSR H RT
307. OO OOOO 1 98 A A 2
308. VP 1 ll 2 16 V V 1 II
309. Y Research question STUDY 2 Research question STUDY srupy A B A
310. ax AUC Y 24
311. ted Sources GPSP3 4 5 HHE2D0 Mi 40 Nakagawa K Kudoh S Ohe Y et al Postmarketing Surveillance Study of Erlotinib in Japanese Patients With Non Small Cell Lung Cancer NSCLC An Interim Analysis of 3488 Patients POLARSTAR published online ahead of prnt May 17 2012 J Thorac Oncol http journals Iww com ito toc publshahead DOI 10 1097 JTO 0b013e3182598abb 8 Jpn J Pharmacoepidemiol 2009 June 14 1 53 41 V 5 1 ll J p
312. vailable from URL http Www ema europa eu ema index jsp curl paqes requlation document_listing document_listing 000345 jsp amp mid WC0b01ac058058f32c GVP GPSP IX 3 CIOMSW EU GUIDELINE MODULE CSRs AERS DB ICSRs
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