日本核医学会 分子イメージング臨床研究のための PET 薬剤の基準 I
Contents
1.2.
3.
4. FE BE 8 4
5. 2 6 4
6. 28 1 2 3 2 0330001 3 3 28 3 1
7. 3 2
8. 1 2 3 4 1
9. 1 2 3 4 1 PET
10. Fae Dl GMP 1 0330001 3 3 10 10 8 lt gt 13 PET PET
11. GMP 2 5 4 10 00 93 1836 2012 10 3 GMP 5 5 3 11
12. GMP 1 A5 1 1 5 2 A5 1 1 5 3 A5 1 1 5 4
13. mi PBT GMP 1 2 3 4 GMP 3 2 1
14. lt gt 7 1 10 PET 3 PET HPLC GC 44 136
15. 1 2 PET 3 MBq ml 1 4 5 6 PET 7 PET
16. 7 2 30 1836 2012 10 3 2 2 3 3 PET 3 3
17. PET PET PET
18. 28 136 5 2012 10 3 2 2 3 2 PET 2 17 5 1 6 1 10
19. RE T lt gt 6 1 6 PET
20. 10 lt gt 15 PET
21. 9 0
22. SOP 1 2 PET 3 MBq ml 1 5
23. HEPA 3 g 6 PET oo HEPA
24. 1
25. 65 1836 2012 10 3 3 3 13 11
26. 14 14 GMP 1 15 1 1 2 15 1 2 3
27. 5 1 5 1 6 119 136 2012 10 3 6 9
28. 70 GMP 1 14 1 1 2 14 1 2 3 14 1 3 4
29. 1 PET 1
30. 3 9 3 34 136 HEPA 2012 10 3 2 2 3 7 1
31. PET PET PET PET
32. 2 13 il ei
33. PET Ne PET GMP 7 1 3 PET 7 1 4 6 1 11 PET 7 1 6 PET GMP 1
34. tN GMP 1 1 24 1 2 0330001 3 3 8 3 0330001 3 3 8 7 4 0330001 3 3 8 5 6
35. 3 5 2 5 4 1 5 4 2 5 4 3 5 4 4 5 4 5 5 4 6 5 4 7 5 4 8 5 4 9 4 1 6 1 3 6 1 8 6 1 5 7 1 2 1 2 PET PET 2 1 PET PET PET PET PET PET 2 2 PET PET lt gt PET PET PET PET
36. GMP 1 GMP 6 20 2 3 5 2 GMP 6 21 3 0330001 3 3 10 10 4 GMP 6 22 5 GMP 6 32
37. 2 3 PET 4 PET PET
38. GMP 3 12 3 6 GMP 3 12 3 7 GMP 3 12 3 8
39. 12 9 1 6 1 8 7 1 9 9 1 9 1 2 9 2 12 lt gt 6 1 8
40. 8 10 E E 7 1 1 PET lt gt 7 1 1 7 1 2 PET uy
41. 3 4 5
42. MI 52 136 2012 10 8 3 3 3 3 6 1 5 6 1 5 3 6 1 5 PET
43. PET PET PET PET 4 21 GMP 4 11
44. 24 1 43 136 2012 10 3 2 2 5 8 5 2 5 3 5 2 5 3
45. 1 NM IN
46. GMP F PET GMP PET GMP
47. 3 6 5 27136 2012 10 8
48. GMP 1 8 1 4 1 2 3 5 2 131136 2012 10 8 8 1 5 3 8 1 7 4
49. 12 gt 15 PET 1 2 3 4 5 1 GMP 2 3 PET GMP 4
50. PET PET GMF GMP 1 12 1 2 12 4 3 GMP 9 20 4 GMP 9 22 66 1836
51. i 8 4 or gt 5 3 PET
52. lt gt 5 3 PET PET Certifcate of Analysis
53. GMP 1 GMP 4 80 2 GMP 4 81 3 GMP 4 83 4 GMP 4 84 118 136 2012 10 3 6 6 8
54. 16 1 3 6 1 11 6 1 3 7 1 2 6 1 6 6 1 7 6 1 10 7136 2012 10 8 3 5 4 9 16 16 1 PET 16 1 1
55. 9 13 13 13 1 13 13 1 3 13 13 1 3 13 13 9 13 18 1 PET PRT PET
56. GMP 2 4 2 GMP 2 4 3 GMP 2 4 4 GMP 2 4 5 1
57. GMP 1 0380001 3 3 10 10 2 GMP 6 42 8 GMP 2 15 56 136 a 2012 10 3 6 lt gt 13 PET PBET
58. lt gt 7 1 11 11 12 13 14 15 16 85 1836 a
59. 6 1 11 7 1 4 7 11 6 1 11 6 1 10 9 1 2 9 1 2 1 7 1 1 7 1 2 11 1 2 2 10 11 12 1 2 13 1 3 14 1 2 GMP 1 GMP 2 51 2 GMP 2 51 3
60. 1 1 GMP 1 10 6 71 136 2012 10 8 4 4 3 2
61. 8 8 1 PET 8 1 1 8 1 2 8 1 8 PET 8 1 4 8 1 5 8 2 PET
62. 7 7 GMP 1
63. 1
64. GMP 3 10 5 82 136 2012 10 8 5 5 2 9 5 3 7 1 1 7 1 1 7 1 1 7 1 1 9 lt gt 7 1 1 7 1 2 PET
65. 25 GMP 1 26 1 1 2 2 23 3 3 24 6 4
66. lt gt 6 1 7 PET Eg mil GMP 1 GMP 3 30 2 0330001 3 3 8 GMP 3 30 3 GMP 3 30 4 0330001 3 3 8 GMP 3 30 121
67. lt gt 7 1 9 1 Design Qualification DQ PET HPLC tn 2 Installation Qualifcation IQ
68. 4 105136 2012 10 3 5 5 17 25 26
69. 3 IQO OQ 1 1 125136 ip 2012 10 8 3 Operational Qualifcation OQ HPLC 0 RI PON
70. 5 2 1 5 2 5 3
71. iv 6 GMP 14 10 lt 16 136 2012 10 3 1 1 8 8 14 1
72. GMP 2 8 5 12 GMP 2 8 6 94 136 2012 10 3 5 5 9 15 6 1 5
73. 3 4 O k OQ F P 3 ET Operational Qualifcation OQ
74. 12 12 12 12 1 1 12 1 2 7 12 12 1 PET PRT PET 12 1 1 12 1 3 12 1 2
75. 5 98 1836 2012 10 3 5 12 18 5 3 7 1 7 7 1 7 7 1 7 18 lt gt 7 1 7 PET PET
76. 5 10 1 1 10 10 1 10 10 10 10 1 PET
77. 3 PET 4 PET PET PET gt 6 1 4 1
78. 6 1 1 6 1 1 6 1 3 6 1 3 16 6 1 1 6 1 1 1 2 6 1 1 6 1 1 1 6 1 1 6 1 1 6 1 3 6 1 3 16 6 1 3 6 1 3 2
79. 2012 10 3 2 2 7 46 136 2012 10 3 2 2 8
80. 3 PET 5 PET GMP 1 20 1 20 2
81. 1 1 2 a 4 PET PET OR PE 4 MWL ED
82. 6 7 GMP 3 12 4 GMP 2 5 2
83. 11 1 3 0330001 3 3 11 7 0330001 3 3 11 7 2
84. 3 3 3 3 GMP 2 8 1 1 2 3 4 4 1
85. 1 1 2 2 2
86. 12 12 GMP 1 2 3 GMP 3 6 4 GMP 4 30 GMP 4 30 WHO
87. HHH ET GMP PET k a 3 Rt ud
88. 8 8 1 1 8 1 2 8 1 8 PET 8 1 4 8 1 5 8 2 PET 11 1 3
89. 15 GMP 1 2 3 4 16 2 1 16 2 2 16 2 3 16 2 4 16 2 5 16 2 6 16 2 7
90. hE GMP 1 17 1 2 17 1 3 59 136 2012 10 3 3 7 60 1836
91. i ii iii iv v Vi vii vii ix 7
92. GMP 1 2 3 4 GMP 2 3 1 GMP 2 3 2 GMP 2 3 3 GMP 2 3 4 3 7 1 9 1 2 3
93. 120136 2012 10 3 6 6 10 0 2 8 6 1 7 9 lt gt 5 1
94. E 1 HEPA 6 PET
95. PET a N RT a GMP 19 1
96. gt 6 1 5 PET PET PET PET 1 1
97. 17 2 0330001 3 3 17 8 GMP 15 10 GMP 15 11 oS w 1 20 136
98. GMP 2 8 5 5 GMP 2 8 6 6 GMP 3 8 5 GMP 3 8 5 5 5 15 21 102136
99. 2 3 4 5 6 ET 7 8 9 10
100. 3 PET PET RR ed
101. GMP 1 0330001 3 3 10 10 GMP 6 24 1 2 3 2 GMP 6 25 55
102. GMP 3 12 4 5 GMP 3 10 3 lt gt 7 1 8 PET PET PET 2 1 GMP 1
103. GMP 3 4 5 12 GMP 3 4 7 86 1836 5 2012 10 3 5 4 5 3 7 1 10 7 1 10
104. 19 19 GMP 1 8 1 2 2 8 1 3 3 8 1 6 136136
105. GMP 3 2 2 GMP 3 2 3 GMP 3 2 4 8 9 2 1 2 3
106. 2 PET 1 2 3 3 6 1 9 lt gt 6 1 9 PET
107. 6 1 7 6 1 7 RA 10 gt 6 1 6 PBT 0 ER PET
108. 3 E PET PET GMP 1 21 2 1 2
109. GMP 8 20 8 RO GMP 8 30 NE GMP 8 31 GMP 8 32 10
110. 0 OQ lt gt 9 1 PET A 4 3 PET
111. GMP 11 70 3 ICH GMP 11 71 4 GMP 11 72 5 GMP 11 73 6
112. 0330001 3 3 23 3 7 1 29 136 2012 10 3 4
113. 38 1836 2012 10 3 2 2 3 7 4 13
114. 12 1 3 12 1 2 12 2 PET 12 1 3 gt 12 PET UN 1 2 ZS
115. 6 11 11 11 1 11 11 1 1 11 1 2 2 11 11 1 2 3 11 2 6 11 11 1 PET 11 1 1 11 1 2
116. OQ 6 1 10 6 1 10 6 1 10 6 1 10 6 1 10 PET lt gt 6 1 10
117. 19 1 2 19 2 21 136 2012 10 8 3 19 3 4 0330001 3 3 19 4 5 0330001 3 3 19 5 GMP GMP 6 GMP
118. 5 3 11 6 1 5 7 1 8 7 1 8 5 1 9 9 1 1 9 1 1 7 1 11 7 1 11 8 8 7 1 11
119. GMP 1 15 29 3 1 c 2 15 29 3 1 d 3 15 29 3 1 b 4 15 29 3 1
120. GMP 3 22 6 GMP 3 1 1 6 29 0330001 3 3 19 5 1 2 7 25 1 2 8 a PR ow 103136
121. 49 136 2012 10 3 3 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 3 9 3 10 3 11 3 12 3 13 3 14 50136 2012 10 8 3 3 1
122. GMP 1 0330001 3 3 11 8 2 GMP 10 31 GMP 3 1 2 3 GMP 10 32 GMP 3 15 3 5
123. id H RY HI LH HH
124. 3 4 6 1 4 6 1 4 4 6 1 4 6 1 4 3 lt gt 6 1 4 1 2 6 1 5 3
125. 4 PET 3 5 GMP 1 1 92 136 2012 10 8 GMP 3 13 2 2 GMP 3 13 4 3
126. PET PET PET 2 PET PET
127. 3 PET pH PET PET ny PET 3 ic
128. 6 1 8 6 1 8 1 17 PET 17 1 PET GMP 36 2 PET 17 2 PET PET 32 167 GMP 1 9
129. GMP 1 10 8 K3 2 GMP 4 60 GMP 4 61 GMP 4 62 O Q GMP 4 64 GMP 4 65 GMP 4 66 00 J GMP 4 63 9
130. 2 3 5 2 3 5 4 1 5 4 2 5 4 3 5 4 4 5 4 5 5 4 6 5 4 7 5 4 8 5 4 9 2 4 1 PET PET PET PET lt gt PET
131. 4 5 2 6 1 1 6 1 1 6 1 3 6 1 3 4 lt gt 6 1 1 1 PET
132. 9136 2012 10 3 0330001 3 3 12 3 12 3 3 GMP 9 21 4 GMP 9 21 o 10 136 5 2012 10 3 1 1 5
133. ep ne eee PET PET PET PET
134. PET F 18 FDG pH PET 1 PET F 18 FDG 1 PET N 13 O 15
135. gt 6 1 6 PET 1 lt gt 6 1 10
136. 8 PET PET 0 GMP 1 17 1 19 136 2012 10 8
137. GMP 3 13 3 2 6 GMP 3 12 3 1 2
138. 2 3 PET 4 PET PET PET
139. GMP 3 6 5 2 GMP 10 11 2 3 3 PET RNN NN
140. 14 14 PET 3 PET
141. 2 7 7 1 11 lt gt 7 1 11 1 2
142. 3 2012 10 8 6 1 9 6 19 6 1 9 6 1 9 7 1 10 7 1 10 7 1 10 7 1 10 5 2 61 136 3
143. lt gt 11 1 2 PET 3 HH
144. 2 3 GMP 3 11 4 lt gt 7 1 9 1
145. 7 1 10 lt gt 7 1 10 PET 7 A PET IO HPLC GC H
146. 6 1 9 6 1 9 7 1 10 7 1 10 6 1 9 Ls lt gt 6 1 9 PET H 7 7 1 10 8 3
147. Q7 GMP GMP 5 11 136 oS w 1 oo Co 2012 10 3 14 1 14 2 0330001
148. 5 2 5 3 5 1 6 1 9 6 19 7 1 10 7 1 10 6 1 6 6 1 6 17 17 lt gt 5 2 0 UI
149. 7 1 10 lt gt 7 1 10 PET PET 42 136
150. Re 4 PET 5 GMP 1 8 GMP 2 5 1 2 GMP 3 12 3 80 1836 2012 10 3 3
151. 0330001 3 3 20 3 4 20 3 30 gt 8 136 5
152. F PET I
153. 2012 10 3 1 1 4 3 5 4 1 5 2 3 4 3 3 5 2 3 7 1 3 7 1 4 7 1 6 3 7 1 6 3 2 15 7 1 6 6 111 3 1 3
154. 7 1 2 5 3 7 1 2 7 1 2 11 lt gt 5 3 1 PET GMP GMP 1
155. GMP 4 75 10 GMP 4 76 116 136 5 2012 10 8 6 6 6 2
156. 2012 10 3 GMP 3 1 2 9 GMP 3 1 3 10 GMP 3 1 4 11 GMP 3 21 104136 2012 10 3 5 5 16
157. 13 2 4 6 8 26 1 1 2 1 31 136 2012 10 8 2 2 3 4
158. 16 1 1 16 1 2 16 1 3
159. 4 PET PET PET GMP 1 GMP 9 10 2 GMP 6 40 3 0330001 3 3 10 10 4 53
160. 76 136 2012 10 3 5 5 1 5 3 16 1 5 3 5 3 16 5 3 2 7 1 1 7 1 1
161. 15 5 1 4 77 136 1 5 3 PET PRT sv 2012 10 3 PET
162. 2012 10 3 3 33 8 GMP 7 51 9 GMP 7 52 10 GMP 7 53 11 GMP 7 60 115 136 4 6 2012 10 8 6 6 1 5 2 5 2
163. 5 1 5 1 5 2 21 6 1 5 6 1 5 PET lt gt 6 1 5 PET PET PET PET 1
164. A WAC RY GMP 1 7 1 0330001 3 3 7 5136 2012 10 3 i
165. 13 GMP 1 14 22 1 2 14 22 2 3 14 22 3 4 14 22 4 5
166. gt 8 PET PET PET GMP 101136 ea RN
167. 3 5 4 1 6 1 5 4 3 PET 3 1 PET PET PET PET 8 2 PET PET PET PRT lt gt E
168. PET 000 GMP 1 19 1 19 2
169. GMP 3 5 3 7 GMP 3 5 4 8 GMP 3 5 5 9 GMP 3 5 6 10 GMP 3 4 4
170. 9 CSV 5 4 4 OQ PQ 25 136
171. 1 Design Qualification DQ PBT V 2 Installation Qualification IQ 3 Operational Qualification OQ
172. GMP 11 80 DQ 1Q 3 OQ PQ 2 GMP 11 30 3 GMP 11 30 3 OQ 4 GMP 3 5 1 5 GMP 3 5 2 6
173. 14 1 4 134136 2012 10 8 5 14 1 5 6 14 1 6 1 2 3 5 135136 2012 10 3 6 6 21
174. 87136 7 1 10 7 1 10 2012 10 3 5 5 5 53 MI97iW0 88 1836 5 2012 10 3 5 5 6 11 5 3
175. GMP 4 80 2 GMP 4 81 4 GMP 4 83 5 GMP 4 84 62 136 5 2012 10 3 3 3 10 10
176. rr gt 6 2 PET PET GMP 1 10 6 2
177. 2012 10 8 3 9 9 9 lt gt 6 1 9 6 1 9 6 1 9 7 1 10 7 1 10 6 1 9 6 1 9 7 1 10 7 1 10
178. 2 6 1 5 72 136 3 a RN 2012 10 8 PET F GMP
179. 2012 10 8 2 2 1 5 1
180. 126 136 2012 10 3 6 6 15 15 13 15 15 1 1 15 1 2 13 15 15 1 PET 15 1 1 PET
181. 96 1836 2012 10 3 3 10 4 4 GMP 3 14 1
182. A5 1 1 6 5 A5 1 2 2 129 136 2012 10 8 6 6 17 15
183. 1 2 PBT 3 I ul
184. 7 1 6 6 1 5 11 3 PET 3 1 PET PET PET PET 8 2 PET PET PET PET gt B
185. 2 PBET 3 ff 5 PET 4 GMP 1 15 1 1 2
186. 4 2 3 PET
187. GMP 3 9 3 lt 6 GMP 3 9 5 7 3 GMP 3 9 6 83 186 ea RN 2012 10 8 8
188. 0380001 3 3 10 8 13 08330001 3 3 10 14 GMP 5 23 15 GMP 5 23 16 GMP 5 23 5 17 GMP 5 23 6 18 GIMP 5 23 7 19 GMP 5 23 9 6 6 3 111 136 2012 10 8
189. GMP 3 21 ON 75 136 2012 10 3 5 5 1 5 2 5 3 5 4 5 5 5 6 5 7 1 5 8 5 9 5 10 5 11 5 12 5 13 5 14 5 15 5 16 5 17
190. 107136 2012 10 8 6 6 1 5 2 6 1 16 1 1 5 2
191. 11 1 5 4 GMP 3 13 5 2 3 5
192. 15 lt gt 6 1 5 PET PET PET PET 1 1
193. 16 2 8 16 2 9 00 NM Oo OT 41 136 5 2012 10 3 2 2 4 5 1 5 2 5 2 5 3 5 3 5 1 17
194. 5 2 5 3 6 1 9 7 1 10 8 lt gt 5 2 i E 2 PET 1 2
195. GMP 1 26 1 1 2 3 4 5 6 7 8 9 10 11 12
196. 2012 10 3 1 1 10 10 15 15 15 1 15 15 1 1 15 15 1 3 15 15 1 2 15 1 1 15 1 3 15 15 1 1 15 1 2 10 15
197. OQ lt gt 7 1 10 PET PET HPLC GC 3
198. 1
199. 6 1 10 HEPA 6 1 10 HEPA 6 1 10 2 17 PET 17 1 PET GMP 36 2 PET 17 2 PET PET 32 167 lt gt 17 PET
200. 5 1 5 1 15 6 1 6 6 1 7 6 1 10 15 1 3 5 5 1 PET PET PET lt gt 5 1 1 E m
201. 7 1 1 7 1 1 5 3 7 1 10 7 1 10 3 PQ 7 1 9 7 1 9 7 1 10 7 1 10 5 3 7 1 2 7 1 2
202. GMP 3 21 68 1836 2012 10 8 4 4 1 4 2 4 3 4 4 4 5 69 1836 2012 10 8 4 4 1 5 2 4 1
203. 0330001 3 3 8 7 GMP 4 75 8 GMP 11 66 2 0330001 3 3 8 2 3 122 136 2012 10 3 6 6 12
204. mk ml GMP 1 0330001 3 3 8 1 2 3 4 2 0330001 3 3 8 3 3 GMP 6 40 4 GMP 6 41 63 1836 2012 10 8 3
205. 22 2 lt gt 17 2 PET I
206. PET 16 1 2 16 1 3 5 lt gt 16 1 2 3 4 5 6 7 1 PET 2
207. 15 1 3 4 15 1 4 2 2 3 7 6 40 136 2012 10 8 15
208. A2 1 1 2 A2 1 2 3 A2 1 3 4 A2 1 4 37 136 a RS 2012 10 3 2 2 3 7 3 117 1
209. 24 7 26 GMP 1 15 4 06 2 15 4 06 3 15 4 06
210. GMP 2 51 23 136 2012 10 8 2 2 1 2 2 2 3 2 3 1 PET 2 3 2 PET 2 3 3 PET 2 3 4 PET 2 3 5 PET 2 3 6 2 3 7 2 4 2 5 2 6 2 7 2 8 2 9 24 136
211. 18 1 2 3 18 1 3 0330001 3 3 8 05 i ji iii 17 136 2012 10 3 4 18 2 5 0330001 3 3 8 3 6 0330001 3 3 8 GMP
212. 2012 10 3 3 3 14 12 15 15 15 1 1 15 1 2 I
213. y PET PET PET
214. lt gt 6 1 3 109136 2012 10 8 1 P PET
215. 24 5 2 GMP 4 30 3 WHO GMP 4 31 4 GMP 4 32 5 GMP 4 33 117 136 2012 10 3 6 6 7 8
216. 6 1 3 6 1 3 6 1 3 6 1 3 1 lt gt 6 1 1 PET SOP
217. 78 136 2012 10 3 1 2 3
218. 5 3 5 3 5 1 6 5 2 5 3 5 1 6 1 9 6 1 9 7 1 10 7 1 10 6 1 6 6 1 6 6 1 10 6 1 10 6 lt gt 6 1 9 PET eat
219. GMP 7 32 GMP 7 33 GMP 7 34 GMP 7 33 2012 10 8 6 6 5 5
220. 14 14 2 14 1 3 14 7 14 6 14 2 14 5 8 14 14 1 PET 14 1 1 PET PET 14 1 2 14 1 8 14 2 PET 17 1 1 lt
221. PET 2 3 4 uu o
222. 3 11 5 1 5 1 6 1 10 6 1 10 6 1 10 6 1 10 64 136 2012 10 3 3 3 12
223. a GMP 1 9 23 2 1
224. 2 nl 3 PET
225. 5 2 5 4 2 B 6 1 8 6 1 8 5 2 9 1 11 9 1 6 1 8 lt gt 6 1 8
226. 3 4 5 6 81 136 ea EN 2012 10 8 7 E 8 9 10 Eg 1 2 ED 3 4 5 SOP 6 7
227. PET 1 PET PET GMP PET 23 3 1 PET lt gt PET 3136
228. in GMP 8 33 11 GMP 8 34 12 GMP 8 35 13 GMP 8 36 73 136 2012 10 8 4 4 4
229. GMP 1 11 1 1 2 0330001 3 3 11 2 3 0330001 3 3 11 3 1 2 3 4 GMP 3 9 1 5
230. 123136 2012 10 8 6 6 13 11 11
231. 2012 10 3 0330001 3 3 11 5 1 2 3 4 2 0330001 3 3 11 6
232. HEPA 6 PET HEPA
233. 1 lt gt 7 1 8 PET PET PET 2 1 GMP 1
234. 1 PET 2 3 PET 4 PET WY 58 136 2012 10 3 5 6 7 8 PET PET
235. 10 1 1 10 1 2 10 1 3 PET lt gt 10 PET lt PET
236. 17 gt 5 1
237. 5 2 6 1 5 6 1 5 6 1 4 6 1 4 4 6 1 5 6 15 6 1 4 6 1 4 6 1 4 6 1 4 2 lt gt 6 1 5 PET PET PET PBT 1
238. 6 1 5 6 1 5 5 2 5 2 5 1 51 136 2012 10 3
239. lt 12 12 5 2 PET PET PET PET lt gt 5 2 mi GMP 1
240. 2012 10 8 29 2 7 25 1 2 128 136 2012 10 3 6 6 16
241. 11 1 2 1 PET 11 1 2 2 11 1 2 1 11 1 2 8 11 1 2 2 11 2 PET 11 1 2 3 lt gt 11 MI SI 1 Me
242. GMP GMP 2 8 2 2 GMP 2 8 3 3 GMP 2 8 4
243. 15 1 2 PRT 15 1 8 lt gt 15 PET 1 2 3 4 5 1 GMP 2 3 PET GMP 4
244. GMP 1 GMP 2 8 2 2 PP GMP 2 8 4 3 GMP 2 8 6 4
245. 6 PET lt gt 7 1 10 PET PET HPLC GC H pF HH 4 KK3 GMP 1
246. 8 13 13 6 1 5 7 lt gt 6 1 5 PET PET PET PET 1
247. 14 22 6 6 14 22 7 7 14 22 8 8 14 22 9 2 2 3 7 5 39 136 2012 10 3
248. 2 3 4 5 6 7 8 9 E E E 10 1 2 3 4 5 SOP 6 7
249. 15 1 2 13 136 2012 10 8 3 2 2 15 2 4 0330001 3 3 15 7 5
250. GMP 4 92 GMP 4 93 GMP 4 93 GMP 4 94 GMP 4 95 GMP 4 96 GMP 4 97 GMP 4 98 OO Ao OO Rw MN 36 1836 5 2012 10 3 2 2 3 7 2
251. 4 15 4 06 I 106 136 2012 10 3 6 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 6 9 6 10 6 11 6 12 6 13 6 14 6 15 6 16 6 17 6 18 6 19 6 20 6 21
252. 17 6 1 6 5 1 16 GMP 1 8 1 2 2 8 1 3 3 8 1 6 17 gt 5 1 0
253. 3 lt gt 5 3 PET H 1 Rn Ng RA 3
254. GMP 3 14 2 2 GMP 3 14 3 5 GMP 3 14 4 6 GMP 3 14 5 5 97 1836 a 2012 10 3 5 11 17
255. GMP 3 10 5 84 136 2012 10 3 5 5 3 10 9 1 1 9 1 1 7 1 9 7 1 9 7 1 10 7 1 10
256. 2012 10 3 6 6 20 PET PET 6 1 1 6 1 1 18 1 8 1 PET
257. E 4 RM tT 15 136 2012 10 8 PBT PET 16 5
258. PET ts 1 PET N 13 1 GMP E E 1 10 1 2 3 4 GMP 7 30 5 6 7 8 9 113 136 10 2 10 3 GMP 7 321
259. PET a PET 1
260. 5 E 3 4 a 2012 10 3 2 2 6 SR
261. GMP 1 3 2 4 1 4 2 5 1 1 6 1 2 6 3 6 4 7 5 2 ON 4 136 1 2012 10 3 1 1 2
262. 7 1 9 7 1 9 9 1 1 9 1 1 7 1 10 7 1 10 10 gt 7 1 9 4 Design Qualifcation DQ PET HPLC 5
263. GMP GMP 13 20 1 2 3 2 GMP 13 21 1 2 3 5 6 3 57 136 2012 10 8 3 6 7 6 1 5
264. PET OQ 4 Performance Qualification PQ PET 3 PQ PQ
265. GMP 2 14 14 136 5 2012 10 3 1 a 1 7 7 12 12 12 1
266. Installation Qualification IQ IQ OQ 6 Operational Qualifcation OQ HPLC RI
267. 19 2 19 3 0330001 3 3 19 GMP 0330001 3 3 19 5 2 0330001 3 3 19 05 3 GMP 0330001 3 3 19 5 4 0330001 a RWWM 67 136 2012 10 3 3 3 19 5 5 GMP 3 22 6
268. PET Performance Qualifcation PQ PQ PQ 11 9 gt PET 35136 E i a RR 2012 10 3 F 18 FDG F 18 FDG
269. i i iv 2 42
270. GMP 3 12 3 1 2 3 5 4 GMP 3 12 3 5
271. 0330001 3 8 9 3 10 1 0330001 3 3 10 2 0330001 3 3 10 0330001 3 3 10 7 0330001 3 3 10 0330001 3 8 10 0380001 3 8 10 1 0330001 3 3 10 0330001 3 3 10
272. 32 136 2012 10 3 2 2 3 5 PET PET 6 6 9 3 GMP
273. 8 1 8 5 8 1 10 11 132136 2012 10 8 6 6 19 PET 0 5m 5 1 6 1 10 6 1 10 6 1 10 133136
274. GMP 12 13 1 GMP 12 13 2 10 GMP 12 13 3 11 GMP 12 13 4 12 GMP 12 12 12 136 5 2012 10 3 1 1 6
275. 2 3 PET GMP
276. 19 3 0330001 3 3 19 4 0330001 3 3 19 5 GMPF 2 3 GMP 4 6 0330001 3 3 19 6 2 3 a Rw NM 127136
277. 2012 10 3 PET 1 PET PET 2 3 4 PET 5
278. ICHQ2A PET Guidance PET Drugs Current Good Manufacturing Practice CGMP GMP 1 GMP 3 4 4 2
279. 11 1 3 gt 8 1 2 3 4 PET PET 5 PET
280. 12 4 5 2 PET PET PET 1 GMP 1 2 3 A2 1 3 A21 42 45 136 PET A2 1 A2 1 2
281. PET E GMP 1 GMP 3 13 3 2 GMP
282. 2012 10 8 HPLC GC 3 GMP 1 GMP 4 60 2 GMP 4 61 3 GMP 4 62 4 24 5 5 10 6 6
283. 3 13 4 3 11 5 95 1836 2012 10 8 5 5 10 16 7 1 8 7 1 8 7 1 8 16 7 1 8 PET 1
284. 2012 10 3 2 2 2 26 136 2012 10 8 2 2 3 1 PET 1 5 2 6 1 9 5 2 6 1 9 6 1 9 DQ IQ OQ PQ 5 2
285. 3 4 7 5 5 14 20 100 136 a 2012 10 3 7 1 11 7 1 11 8 20 gt 7 1 11 1
286. PET PET 5 5 5 1 PET PET PET lt gt 5 1 3
287. GMP 12 90 7 GMP 12 93 8 GMP 3 4 5 9 GMP
288. 19 1 19 2 19 3 0330001 3 3 19 0330001 3 3 19 1 GMP 0330001 3 3 19 05 2 0330001 3 3 19 05 3 GMP 0330001 3 3 19 5 0330001 3 3 19 5 5 GMP 3 22 6
289. 1 7 4 PET 7 4 0
290. 3 3 2 1 1 lt gt 6 1 5 PET PET 0 1 PET
291. 3 i PET TE FDA Guidance PET Drugs Current Good Manufacturing Practice CGMP GMP 12 10 GMP GMP 4 91
292. GMP 10 14 1 2 3 89 1836 2012 10 3 GMP 3 6 4 GMP 3 6 6 90 1836 2012 10 3 5 5 7
293. GMP 5 30 3 GMP 3 31 4 24 6 1 2 3 5 24 7 1 2 6 GMP 3 32 7 GMP 114 136
294. 11 GMP 3 10 1 12 GMP 3 10 2 13 GMP 3 10 3 14
295. 2 3 4 gt 11
296. 2012 10 8 7 E 18 9 20 EN 8 9 10 11 12 SOP 13 14 GMP 1
297. 5 2 3 5 2 6 1 1 6 1 2 6 1 9 5 1 6 1 7 3 GMP 1 10 4 2 10 6 3 10 7 4 GMP 7 10 112 136 2012 10 8 6 6 4
298. GMP 3 6 1 GMP 3 6 2 GMP 3 7 1 GMP 3 7 2 1 2 3 5 6 7 8 GMP 3 7 3 4
299. GMP 4 33 91 136 5 2012 10 3 5 8 14 5 3 7 1 2 7 1 2 7 1 2 7 1 3 7 1 3 11 11 14 lt gt 7 1 1 7 1 2 PET
300. 1 1 EX Design Qualification DQ 9 1 E PET Installation Qualification IQ f rT 2
301. 5 1 GMF 2 3 PET GMP 4 PET NM GMP 1
302. a 2012 10 3 PET 1 Ver 1 1 2 3 4 5 6 1 2012 10 1 136 2012 10 8 1 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 10 1 11 2 136
303. 6 1 9 6 1 9 5 1 6 1 6 6 1 6 5 2 6 1 9 9 1 9 5 1 6 1 6 6 1 6 6 1 7 6 1 7 5 2 5 1 6 1 10 6 1 10 108 136 2012 10 8 6 6 2
304. GMP 1 16 1 1 2 16 1 2 3 2 16 1 3 43 16 2 5 2 0330001 3 3 16 5 i
305. PET i W GMP 1 GMP 10 12 2 GMP 10 12 3 GMP 10 13 4 GMP 10 13 4
306. GMP 3 9 7 9 GMP 3 9 8 10 GMP 3 9 9 2 3 4 5 6
307. gt 14 GMP 1 2 3 5 6 7 PET GMFP 18 4 i GMP 1 18 1 1 2
308. 15 1 PET 15 1 1 PET 15 1 2 PET 15 1 3 lt gt 15 PET 1 2 3 4
309. 1 2 3 0330001 3 3 10 10 0330001 3 3 10 10 0330001 3 3 10 10 GMP 5 41 GMP 8 37
310. 6 1 1 7 6 1 4 6 1 3 4 5 2 5 1 5 1 5 1 5 2 5 1 5 1 6 1 10 6 1 10 70 136 2012 10 3 4 4 2
311. Du x a se T a y GMP 1 19 1 2 19 2 19 3 0330001 3 3 19 GMP 0330001 3 3 19 5 2 0330001 3 3 19 5 3 GMP 0330001 3 3 19 5 4 5
312. GMP 47 136 2012 10 3 48 136 2012 10 3 2 2 9
313. gt 6 1 4 H 6 1 5 lL nl 2 I Di Zu I PET
314. 5 13 99 1836 2012 10 8 19 9 1 1 9 1 1 9 1 9 1 2 19 lt gt 9 1 1 ICH
315. 0330001 3 3 8 8 0330001 3 3 8 4 18 136 2012 10 8 1 1 9
316. 18 1 1 ed 18 1 2 PET 18 1 8 PET lt gt 13 PET PET 1 2 PET 3 PET 4 PET 5 6 7
317. 5 2012 10 3 1 1 1 1
318. 136 2012 10 3 0330001 3 3 10 10 5 GMP 6 21 54 136 2012 10 8 3 3 4 4 6 1 4 6 1 4 6 1 4 6 1 4 4 6 1 4 PET lt
319. 136 5 2012 10 3 6 6 11 10 5 1 6 1 7 6 1 6 10 5 1
320. GMP 4 31 GMP 4 32 GMP 3 6 4 GMP 3 6 4
321. 136 2012 10 3 3 3 5 5 6 1 5 6 1 5 6 13 13 6 15 615 5 6 1 5 PET lt gt 6 1 5 PET PET
322. 2012 10 8 5 15 1 1 15 1 2 21 15 15 1 PET 15 1 1 PET 15 1 2 PET 15 1 8 lt gt 15 PET
323. IQ OQ F Operational Qualifcation OQ HPLC RI OQ H GMP 1 2 3
324. 3 3 14 3 0330001 3 3 14 0330001 3 3 14 5 GMP 12 10 GMP 12 11
325. 3 21 7 GMP 3 22 GMP 3 23 QMS 23 6 9 Co 22 136 2012 10 8 1 1 11
326. Design Qualification DQ NT PET HPLC 79 136 2 3 a 2012 10 8 Installation Qualification 1Q
327. e 5 15 29 3 1 f 6 15 29 3 2 a 7 15 29 3 2 b 124136 5 2012 10 3 6 6 14
328. 1 7 2 0330001 3 3 7 6 16 155 15 210 8 242 3 7 3 0330001 3 3 7 4 i 4 7 4 i
329. 21 2 2 3 21 3 4 21 4 130 136 2012 10 3 6 6 18 16 5 1
330. 4 5 7 5 0330001 3 8 7 6 136 1 2012 10 3 1 3 3 16 16 1
331. PET GMP 1 10 1 2 10 2 3 10 3 4
332. 1 2 3 4 5 33 136 2 0 2012 10 3 2 3 6 LE AL 5 1 6 1 10 6 1 10 6 1 10 PET lt gt 6 1 10
333. 11 PET 10 8 GMP 1 0330001 3 3 10 2
334. 6 PET 7 PET PET F 18 FDG pH J HH BI 1 PET F 18 FDG 1 E O 15 E E
335. 8 0380001 3 8 10 8 0330001 3 3 10 08 7 0330001 3 3 10 8 0330001 3 3 10 2 0330001 3 3 10 10 0330001 3 8 10 110 136 2012 10 3 11 0330001 3 3 10 8 gt 12
336. GMP 8 43 GMP 8 43 74 136 2012 10 8 4 4 5 10
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