日本核医学会
Contents
1.2.
3.
4. PET
5. PET Ww Xl
6. m S Kx
7. q 0 05 0 1 B 0 1 0 2 Phase I 15 80 Phase Il 100 Phase 100
8. Tut 4 8 2
9. 46 T A j
10. 1 9 2 standard operating procedure
11. 4 3 1 2 Re PET
12. 4 9
13. 4 10 HH
14. PET 35
15. alternative replacement 4 16 ICH E10 18 2 27 186 4 16 1
16. imtention to treat intention to diagnose
17. fa 76 I TL
18. 1 19 2 3 4 1 2 3 4 lt gt 7 1 3 7 1 4 7 1 6 REF 4
19. 12 1 1 12 1 1 ang 12 1 2 12 1 1 D D GD EE T
20. by ETS 3 3 3 1 Phase Il 3 3 3 2 Phase IL
21. 4 16 4 1 2 1H 1
22. PET Certifcate of Analysis A 1
23. 8 10 5 4 6 PET 6 1 PET PET PET 6 1 1 PET
24. PET 4 6 1 ou
25. H EROR W E 2 3 F
26. PET 1 PET 2 H 3 4 5 6
27. D gu gt 9 1 1 IC ue F N
28. 14 1 2 GMP 14 1 3 G P N f S 14 2 GMP
29. MCA Nal E Ge L MCA
30. 12 PET GMP Does
31. gt Wt CTCAE Common Terminology ash X Criteria for Adverse Events v3 0 28
32. 36 2 PET PET 1 3 ES APPEL DT APE 2
33. lt gt 6 1 TRA OHA KL BT mop boll lt gt 6 1 8 1 Design Qualification DQ
34. Phase z lt 3 2 3 69 3 2 3 1 PET I
35. Bil 2 EET D LLT panc Et LAHM AST ATT aa 67 BUN Cr ALP LDH Na K Cl PHAR TFDP PT APTT RIRE 1 2 jaz eA
36. 3 ESSA BY HEY 8 A GES J o ZD PET BRIEDE E 7 FB RICE Rear in i E
37. 1 PET Ace pena ar genau We
38. 74 4 4 PET XANI HR 4 4 E gt 1
39. 1 3 O 2 3 4 E1 PET TLC ITLC
40. 1 WIEBE partial verification
41. ELUX acl Ett ER BT St mt li ER BT Y CRF CRF Eau me S X 4 3 1 PET
42. ROI PET PET
43. 1 1 1 PET PET 1 2 PET 1 3 PET 1 4 PET 1 5 PE
44. Phase I IL Phase 1 Phase 1 Phase 1 Phase Fi S
45. PET PET PET cGMP for PET drug PET PET PET fi
46. 7 REE 8 9 nH 10
47. ua CRF 1 MV 5 83 RZL AN
48. 2 Or FY WL a EIC Dl gt Eo Tu Shay PU at gt ks SIRIEN TAR RAT 78 ONK BERRO
49. lt hs 64 ROC assay sensitivity
50. 2 disease condition 2 2 es
51. lt gt 6 1 4 1 2 6 1 5 3 PET 15
52. 70 3 3 2 r 3 3 3 Phase Phase
53. IRAE ERE JERI h E ED CA gt E 4 12
54. RAD W O PET FDG PET 2 17 PET GMP GMP FDA RY LAV RES RADIOISOTOPES Vo1 59 No 9 2010
55. PET M 9 7 st N Sa ul ji 2 2 4
56. PET Q7 GMP R a S a X ji rat 25 11 11 1 PET 11 1 1 11 1 2 11 1 2 1
57. Nn 34 1 PET 3 O 18
58. R Mantel Haenszel 4 18 1 BRIZ LT
59. t HE 3 2 3 3 Plase A 3 3 Phasel 3 3 1 Phase
60. 65 3 PET 3 1 Phase I 3 1 1 Phase I
61. 5 5 FJI 5 1 PET 3874 TAR Ee LOS E al Helen i OIG ER WEWER E
62. PET 11 1 1 PET wl 11 1 2 48 11 1 2 ht a 1 5 4 5
63. 4 13 4 13 1
64. X 40 PAs B t i E REC PRA ER EE EER RRRA K i H ER EU RRRA E Ek REFIRE ta ll 3 me EMT ARKO OFR PL HH
65. 8 1 1 8 1 2 8 1 3 PET 8 1 4 8 1 5 8 2 PET 11 1 3 22 lt gt 8 1 2
66. 14 14 1 PET 14 1 1 PET PET 14 1 2 14 1 3 14 2 PET 17 1 1 gt 14 GMP
67. 6 M3 1 5 7 8 f 59 10 7 9 z gt DES q 554
68. ZA I ae E amp E SR FDG PET PET PET PET
69. an CRED au cu ul 17 PET 17 1 PET GMP 36 2 PET 30 17 2 PET PET 32 167 lt gt 17 PET
70. anatomic orientation 2 1 2 PET PET CT au
71. 4 K HPLC PET HPLC H ROAD aa CBOE RE PROPINAS TEU EHATAL OA
72. HERIR Ae 87 amp y 4 7 MOREL BB eens 3 S LV POT lt CT AL 17 FAZ G
73. PET My 3 O ggu AE
74. 31 PET PET PET 1 A A PET y
75. E 37 3 GC HPLC 6 5 5 PET 1
76. RY H HH 82
77. PET Fic O ng St H UIZ oT bas A PET CR NONE
78. E YE BE EHE j E EDIE fe S BE PET PET HPLC GC ke 1 E 5 MELIA H F 3 H
79. 15 1 3 HAXE 1 Ll 52 16 1 1 PET
80. H 3 Pl H 3 WE PETIA HART AIT 3 E H PET ET N 13 A H E 4 PET v H H
81. gt _ 4 13 2 81 4 14 4 14 IRZ au 1
82. 1 PET 38 PET 39 3 HE CHS Be PET me ZB
83. PS ECOG B PS ECOG Performance status 0 1 66 PET 1 500 mm3 75 000 mm3 9 0 g dL AST ALT 100 IU L 1 5 mg dL 1 5mg dL C CER R RANEE OEE d
84. gt 1 1 E B shay WOR 3 eis REE M
85. SZ set EE ul cu sa LASS DRE LRP
86. max max Max Pase specific activity PET Hp ON oA O 3 2
87. ROC 2 ROC BOT 89
88. EEH A KETHEK UKR 9 1 2 PET 47 9 2
89. 3 3 3 3 PhaseI B 8 OS li z 3 3 3 4 71 4 PET 4 1
90. 63 2 PET 2 1 PET 2 1 1 2 1 2 O
91. 11 GMP 8 7 CD PET
92. FE 18 FDG F 18 FDG 3 24 PET FDA Guidance PET Drugs Current Good Manufacturing Practice CGMP
93. T 7 1 5 PET 45 6 PET
94. 5 4 6 51 K BGEA H WET 15 1 1 CMP 15 1 2 PET
95. E 1CH E10
96. H 7 PET 8 2 9 10 11
97. lt gt 6 1 5 s PETRA RD n ae S P 1 2 J BT 3 4 Bee DH CRR ZER B Hn AY Ae PBT fA 1 HH O
98. ELO DN BOA bax EE E jez E
99. A PET Ee H St S 2
100. sft 2 FDA U S Department of Health and Human Services Food and Drug Admnistration Center for Drug Evaluation and Research CDER Guidance for Industry Investigators and Reviewers Exploratory IND Studies 12 January 2006 3 22 1 8 ICH M3 R2
101. 1 2 PET
102. Phase Phase IIL KO Phase WE E cit 3 2 2 Phase TI Phase Phase Phase I
103. 2 2 2 ROC oe Ou J 2 3
104. 3 1 2 Phase I Phase I A
105. BO I oe est We al i Fy mR 5 5 2 PET X BE 5 2 PET E 41 REE mr mj me F K be y A
106. H LH KTS i TO an pag FRB nA ar E PET PET PET yr Hr Call PD H ty H A a TS CORE a H H LO HH a H LE
107. 1 2 3 4 5 SOP 6 7 8 8 1 PET
108. A 4 3 QOL Se mL i PET QOL 4 5 CRF EE CRF CRE 75 PET
109. PET PET o 32 cs as A pe ots Ba ww ERI FAN as B pii HS A s 2 Na po MA PAR AS EL
110. CHQ2A PET Guidance PET Drugs Current Good Manufacturing Practice CGMP lt gt i PET
111. 3 PET E 3 i 20 lt gt 7 1 8 PET PET PET 2
112. 2011 8 gt _ _ GMP ABC A ABCD A GMP ADRA ERARE I i mo 2 PET PET 2 1 PET PET 2 2 PET PET CD me PET Sy 3 1 PET
113. D A 1 1 1 E 4 GG EIZ hes BE H N PET 1 HQ yE ROL 3 j
114. e PET PET 4 5 1 CRE CRE CRE
115. 4 14 2 Pr oR PET pg ee VCH 1 Fmt hi 1
116. PET M3 E Z DZH FE Ames Ames 3 EIJ F MTD MFD 6 7 MIRD 2 BE Medical Internal Radiation Dose Committee
117. PET 2 PET 1 2 3
118. 3 4 16 A LV SRA DS Ht ARSE EY Ae 2 EE E
119. GMP zu 14 1 1 GMP E GMP 50 H
120. gt 15 PET 1 A ES S 3 i S S i oR iat y A 5 3 PET GMP 4 at ay X
121. PET GMP D5 a a 9r 0 A 3 7 gt be ul cu a gt 4 PET 4 1 PET PET PET PET 4 2 4 1 PET PET lt gt PET 7 4
122. A PET 1 2 3 Du
123. T A H E A
124. PET 3 1 3 3 3 2 Phase Il 3 2 1 PhaseII JE
125. PET BUM in OA HE KIA 13 1 1 13 1 3 4
126. ROC 2 2 ROC ROC 1
127. 13 6 1 10 PET 6 1 11 PET 6 1 12 6 2 PET lt gt 6 1 1 FAK MECHA
128. PET 1 1 TS PET 2 PET PET 2 1 PET PET PET PET PET PET 2 2 PET PET gt PET PET PET PET PET
129. PET 2 Installation Qualification IQ Operational Qualification OQ PBT
130. PET PET PET TEELE EZKIL PET ip hts HHA B GMP 0709002 GMP PET
131. 2 73 4 3 1 1 eee
132. CRE FY 4 6 PET
133. gt 6 1 11PET PET PET PET PET lt gt 6 1 12 A lt gt 6 2 PET
134. 1 lt gt 7 1 OF 1 f 2 Es nh h By 4 a But Be ou ae ing up m a 3 gt zu RI OQ
135. PET SOP 1 2 PET 3 MBq ml 1
136. BIL 7 1 10 7 1 11 7 1 11 1 7 1 11 2 7 1 11 3 7 1 12 lt gt 7 1 1 7 1 2 PET
137. PET PET Phase I Phase I dose escalation PET Phase I dose escalation 3 6 4 2
138. 79 FH 2 CRF 4 aa au iI l H 11
139. PET 2011 10 2011 11 PET I Tl I PET POC MO EMEA PET Positron Emission Tomography LHD C tet Ch 0 BON
140. QA OECD 1997a Organization for Economic Co operation and Development OECD 61 OECD Series on Principle of Good Laboratory Practice and Compliance Monitoring No 1 Revised OECD Principles of Good Laboratory Practice ENV MC CHEM 98 17 62 1 EE PET oa PET
141. 2 3 stay DUR EL 80 Yo rg
142. 5 6 P T T 7 P 1 PET F 18 FDG 1 lt gt 6 1 3 PET F 18 FDG par Gig E LAM Daa FSH O 15 1 E HH a PET
143. E 1 E 57 E 0219 4 22 2 19 0219 4 M3 PET 3 3
144. PET fiw 1 E W JESI f 70 e FX K
145. PET 7 4 IK Sa gt
146. PET 9 2 PET 9 1 1 gt 9 1 PET PET
147. D GD fist ot D gi yY 4 HT ek 12 1 3 12 1 2 lul ly ul gl 5 4 5 PET 49 NN
148. 6 PET G 6 1 1 PET PET Bq ml 1 mA PET PET
149. 6 1 8 6 1 9 fae xe hes ke 6 1 10 44 6 1 11 N
150. pea differential verification CUBA Y PCR HA 73 84 E H F
151. 0Q 4 Performance Qualification PQ PETH 3 PQ PQ zu 3
152. PET GMP PET PBT 1 PET lt gt PET PET 1 PET
153. ii Pf PET 2 3 4 PET 5 3 PET 3 1 PET PET PET
154. 6 1 2 PET PET 6 1 3 PET 6 1 4 PET 6 1 5 PET 6 1 6 6 1 7 6 1 8 6 1 9 Ht
155. E HERRA MAE Faw TORM nA PET 4 proof of concept gt a FE PET f PET ZE F
156. 23 PET Bu 4 IK Z 1 2 3 1 lt LIE au YE f3 4 LIE Ra 1E 5 6 3
157. ME LAA tin DSA ff 16 PET me ak my E lt gt 6 1 6 PET
158. 3 PBT PETI PET
159. m lt gt 6 1 9 PET H 1 10 E 1
160. 7 1 5 PET PET PET PET 7 1 6 PET 7 1 7 PET PET 7 1 8 PET 1 7 1 9
161. Dt CHERR S IVS BOURGB LE AGI ETS Z OL SHH BEIT RR enas Un zowa Marcoen 2 85
162. PI 3 Ly ET Su H Hram 5 PBT v 33 E
163. 58 2 3 100 E 3 500ng 2 1 100ng i pmj 2 4
164. PET 16 T 13 13 1 PET PET PET 13 1 1 13 1 2 PET 13 1 3 27 PET
165. 14 2 CTCAE AUC Al HAE EPMA WET D MIRD 68
166. CUC H B RAS ZR GR Pt E
167. P RO i BEY Be ET 1 F E All 5 pH PET P R fi IKAI Ly d P EXT RO A FR BLK E
168. W ED e H F IB T A T A
169. 1 H 3 pH M H E UITA 3 E E72 A ANSE EA E H R N 13 JEA EEA CUE BULA A Hie ICH 3 KASH H tf
170. 60 E OF RM OIR OET iq ROK 3 1 3 1 Phase I 3 3 Su Bil 1 E
171. in vitro yo PET IO 2 2 1 PET radioisotope RI PET 1 GERRY 1
172. 2 100 1 F 19 C 12 100 MD MD 20 6 3 0603001 MD S 1 ZS
173. GMP 0709002 GMP GMP 0330001 FDA PET Drugs Current Good Manufacturing Practice CGMP PET PET o GMP GMP PET BRAS GMP GMP PET FDA lt gt PET PET GMP
174. PET 7 PET 7 1 PET PET PET 18 7 1 1 PET 7 1 2 7 1 3 PET 7 1 4 6 1 11 PET
175. E y HEO CRF CRF 4 Do WA Le 6 W ID
176. PET 3 2 PET PET PET PET lt gt ET PET
177. 29 PET Wh 16 16 1 PET 16 1 1 PET 16 1 2
178. ZOER gt Oni uli 5 5 3 PET 5 3 PET X A A 42 as
179. 1 1 SOP ere
180. lt gt 7 1 11 21 F 1 2 3 4 5 6 7 E 8 9 10
181. 3 4 PET PET 5 PET 9 9 1 PET 9 1 1 9 1 2
182. 7 8 9 10 11 PET 10 8
183. gS 2 2 2 4 100ng 5
184. PBT 3 HELA 5 Tu PET TE 4 12 12 1 PET PET
185. 4 6 2 77 ZN 4 6 1 3 4
186. PET 12 1 1 12 1 2 26 12 1 3 12 1 2 12 2 PET 12 1 3 lt gt 12 PET
187. N 13 H pH te H PET 14
188. 4 10 TE RAR 14 5 3 14 2 5 Mueller L Mauthe RJ Rilley CM Andino MM De Antonis D Beels C DeGeorge J et al Arationale for determining testing and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity Regul Toxicicol Pharmacol 44 2006 198 211 1 1 120ug 100 1
189. 9 4 3 72 2
190. lt gt 7 1 10 Design Qualification DQ ET Installation Qualification IQ HF BLID IQ OQ Operational Qualification OQ 1 E Ah 4y He s AX He IF EEL es HPLC HPLC
191. 16 1 3 5 lt gt 16 1 2 3 4 5 6 7 1 PET 2 ERG 3 PET 5 PET
192. PET 6 1 5 xh 1 mK H E PET Sh PET 6 1 6 6 157
193. lt gt 13 PET PET M 1 PET 2 3 PET 4 PET 5 6 7 IK r 4 HLE ORR a Bu 8 PET PET
194. 16 1 2 16 1 3 5 PET 17 1 PET GMP PET Be PET 17 2 PET JKA 53 KR
195. E E J 88 2 8 McNemar Stuart Maxwell
196. 86 IED AP i ae 4 16 ae FES F 3
197. 9 AIN K E I ZW EU GMP PRET H PET AG
198. AR patty i Ls ul E 7 1 3 eh pi 7 1 4 PET
199. GMP 12 10 n 10 10 1 PET 10 1 1 10 1 2 10 1 3 PET gt 10
200. PET 5 PET Es E 1
201. ats nA H 9 ae B B 3 PET EOE I R Ze HY ARIAT Jo HL TRZE nn AY at piny E im SAB MAREA By MES AE ARR B F A AD TO
202. fai Bul 0 gt Dt see ye Sa aio ay ee 5 5 1 PET PET PET 5 2 PET PET PET PET 5 3 PET PET PET 5 4 PET 5 1 5 3
203. ab y 3 1 3 9 PET 4 1 PET PET
204. PET PET 5 4 1 PET 5 4 2 5 4 3 5 4 4 5 4 5 5 4 6 5 4 7 5 4 8 5 4 9 5 4 10 5 5 PET PET PET PET PET PET lt gt 5 1 3
205. E 4 4 2 gt Lo At 0 a RANN
206. 10 4 7 8 4 JE yH A m PET
207. E A OF oh Ot Ni oe By WUZ E 1 N 7J E h E
208. E PET HE 22 Fl 2009 PET 1 pen WK ICH PET PET
209. are lt gt 7 1 5 Hg o gt lt gt 7 1 7 oh ME SEN ER PET XE Bit 4 Ze gt E E E
210. J 5 4 2 VD 5 1 at ET ou Du 9
211. 6 1 3 N ul cu 43 PET 0 6 1 4
212. PET 11 1 2 2 11 1 2 1 11 1 2 3 11 1 2 2 11 2 PET 11 1 2 3 lt gt 11 1 2
213. 28 1 2 3 4 5 6 7 PET GMP 18 4 15 15 1 PET 15 1 1 PET 15 1 2 PET 15 1 3
214. F 18 F FEDG IR NMR PBT 0 9 PET
215. me 6 1 12 6 2 me 7 PET G 7 1 1 PET i 7 1 2
216. HEPA 6 PET HEPA me XI Sb HY 3
217. 1 1 TE W TH
218. 5 4 2 Ei Ei 5 4 3 10 1 1 5 4 4 5 4 5 12 1 1 1 5 4 5 5 4 6 GMP 55 5 4 6 5 4 7 56 Tl 1 PET
219. PET PET 1 2 me ED PD 3 FSEK L BRC BIS BCA allie 4 PET PET PET
220. RRR LA une Oe eee ce XE bs be Ke 54 5 3 3 Y m 7
221. SOP 3 2 IAS 4 5 6 EHM E 9 a bavi F 60 HOU 1
222. 5 4 3 SS ei z HI pict rr Jr RS a 2w PET 10 1 1 5 4 4
223. A RR Ze FEB E Way Alc ITO LD SD ee Shay PU
224. T PET 1 6 PET 1 7 1 8 PET gt
225. Y 2 1 3 2 1 4 2 2 A D 2 2 1
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