-
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102
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102 81 13 4,483 9,001 1 362 8,000 55 10 1,013 1,001 4 1,177
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-
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1,814 95 3 7 0950061139 ( 1) 95 1 2 0940037980 ( 2)
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5,993
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58 96 100 176 132 13 8 23 64 97 6
2. 30
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96 10 27
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9.
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()
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49
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102 (1).
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-
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- 1 8,482 8,000
1.
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()
-
22
2.
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DNA
knowledge gap
4.
-
23
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5. 3 29 (PM2.5)
6.
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- 1 8,482 8,000 PM2.5
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3. 95
103
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5. PM2.5
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()
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-
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2. 2 35 10 6 1
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3,156 3,000
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4
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102 76 45 121
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5. 102
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318 6,000
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206 5,000 1.
161 5,000
2.45
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30 15 2,000
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-
31
5 2 ) 4
7.
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1,724 3,000 102 1 1
1.
101 8 102 104 101 10 9 10101444186 102 1 1 5
2. (1). 84 3 1
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102
-
32
1 1 6 (2). 101
10 30
6
3.
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145 4.91%
1. (102) 5.17% 4.91%
( 34% 36 %) 206 105
2. 100 1 26 3
-
33
36%102 145 50 () 1 7
3.
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9,473 6,000
1. 101 11 22
23
2.
-
34
(1). 8,134 4,000 7,351.4 33,333.15 ( 4.53 ) 450 1,100 ( 650 )
700 1,500 ( 800 )
(2). 1,159
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3.
() 1 ()
1,159 100 28.23%
1. 100
-
35
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( 100 1,028 9,000 ) 102
(1). 759 10
I.
23 1 9 540 60 9=540
II. 12 23 32
III.
187 IV. 10
(2). 320
(3). 70
3.
-
36
() 1 ()
8,134 4,000
1. 101 11 22
23
2.
8,134 4,000
3. 7,351.4
33,333.15 ( 4.53 ) 450 1,100 ( 650 ) 700 1,500 ( 800 )
4.
(1). 65 6,000 (2). 1,375
6,000 660 5,000
-
37
(3).
118 (4). 31 5,000 (5).
59 5,000
(6). 121 6,000 2 93 4,000
(7).
311 (8). 1,000 (9). 432
1,000 (10).
4,318 7,000 (11).
225 (12). 203 9,000
(13). 117 9,000
5.
-
38
() 1 ()
24 2,536 9,000 4 8,507 4,000
1.
100
2. 102 2 26
2.3.7
102 4 23 102 103 104
3. 101 5 10 6 10 10
4. 101 12 141,007 101 4 136,415 4,592 102 2 101
-
39
5. 101 5 101 12 2,829 1,670 1,159
6. 102
() 1 ()
724 7,000 1/5144 9,000
1. 96
(1). 39
500
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(3). 12
101 3,845 (328 9,000) 0.1%
-
40
115,569 (38,046)0.03%
2.
700 800
() 1 ()
4,603 3,000 1,000
1. 101 12 28
2. 102 2 1
1020268925 3. 102
-
41
105
4. 5.19 5 102 1 370 103 1 370
5.
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4,603 3,000 1,000
1.
2. 102 3 26
3. 102 5 31
-
42
4.
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666 8,000 82
1.
2.
3.
101
9 5
-
43
11 12
4. 82 1 101 10 12 18 102 1 4
5.
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1 2,835 6,000 291 3,000
1. 102 3 27
2.
100 150 4 1
3.
75
4.
-
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103 104
5. 101 12 24 102 1 22
6. 102 7 8
7.
103
() 1 ()
2,314 1,000 1/2 1,157 1,000
-
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1. (1).
100
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102 4 23 102 103 104
(3).
102
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e
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46
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98 49 14 71 10
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508 238
3.
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4 4,000 1/5 9,000
-
47
1. 102
2. 102 724 7,000
101 900 100 1,000 175 3,000 275 3,000
3.
() 1 ()
4,274 5,000 200
100
1.
-
48
2. 99 101
418 16,250 100 34,497 99 31,792 8.5 102 8 22 230,473
3. 102
102 4
4. 100 10 24 11 10 10
5.
101
-
49
(1).
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6.
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20 7,515 3,000 1,500
1. 96-100
15% 23% 5%
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2. 4
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(()
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3.
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6 4,000 (2). 99%89%
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10
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4.
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72 1/236
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48 1 1,300
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2.
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-
52
104
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1. 99 12 21
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-
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4.
-
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() 1 ()
1,440
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101 12 10
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-
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1,440
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1. 101 12 10
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-
56
1
4.
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7,221 6,000
1. 98 2 98 101
-
57
98 4,406 10 14.7 101 3,766 13.1 3 99 3 10 101 11 102 1 6 1,521
101 1 6 2,012 491
2. 102
3. 102 98
6 1,284
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-
58
4. 102
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5. 102
6.
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7,221 6,000 30 3.2% 101 8
1. 101 12
-
59
2.
30 30
3.
4.
3
5.
-
60
() 1 ()
6 9,253 7,000 52
1.
97 2.3% 102 7 27% 12
2. 100 99 1.1 101 100 1.14
3 3.
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101 7 101
1,143 8,000 101 3,846 6,000 102
5,441 8,000 (2).
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-
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(3). I.
II.
III.
ADLIADL CDR 21
IV.
(4).
(5).
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3 1,814 6,000 99
-
62
1.
2.
3.
101 275 99 28 9.24% 98
101 280 102 7 130 101 (175 ) 26%
4. 93 105 101~105
-
63
206 ( 114 )
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31 2,333 6,000
1. 26
90 102 56%56.5 24.51
90 101 146 213.56 46.27%101 100 6 6 4
2.
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-
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I.
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102 3 126 12 102 17 7 ()
(2)
-
66
(3)
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31 2,333 6,000
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09102101431
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56 2 2
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I. 8 1 ()
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3 1,544
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3,310 4,000
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;
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101 1,179 257 (21.8%) 234 ( 91.1%) () 13457.3% 73 (31.2% 45
)
4.
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2. 101
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140
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;
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92 97 NS1
50~90%
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(WPRO)
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-
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4.
5. :
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82
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100 21 748 101 20 4,411
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6,109 5,000
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97 5 6
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102 103
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311 4,000 100 101 1-6
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3. / 5
101 1-6
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1 9,924 1,000
1.
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No Observed Effect Level, NOEL 10010 10
Acceptable Daily Intake, ADI
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3.
-
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4
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() 6 ()
48 6,000
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(ICH-GCG)(CDER Forum)(FIP)
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( 6) 101102 ( 7)
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()
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4. 101 9 12 11 20
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2 5,743 2,000
1.
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101 2,363 2,121 ( 89.8%)
3.
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5,186 2,000()
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100 102
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4.
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101 1 1 8 3 () 20 3 102 1 104 12 31 7 101 1 103 12 31 20
2. 3 101-102 3 2
-
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3.
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call center
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5. 102 1
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(99 7 -100 6) 3 3 ( 1 2 ) 1 ()
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102
(5).
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() 5 ()
7 6,211 1,000 4 2,251 4,000
1. 84 700
84 2 8 04391
2.
84 10 12 36085
3. 102 7 5
-
103
99.68% 99.25%
4.
() 5 ()
4 2,251 4,000
1. 84
84 10 12 36085
2. 102 7 5 99.68%
3.
() 5 ()
315 6,000 (Tw-DRG)
1. Tw-DRG 5
-
104
99 1 Tw-DRGs 1 2
DRG 2
2. 100 6 101 8
101 12 1 DRG
101 12 1 102 4 30 102 4 19 102 9 30
3. DRG 2 100 11 18 102 5 17 2
102 2
4. 1 Tw-DRGs 101 12 98 1-12 4.39 101 12 4.13 5.92%102 1 4.09 1
0.90%98 1-12 45,511 101 12 45,320 0.42%102 1 46,179 1 3.06%
-
105
Tw-DRGs 4
5. DRG 101 8 - Tw-DRGs
6.
7.
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4,118
1. 6
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-
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101 2,238 102 8 1,094
3.
4.
() 3 ()
785 5,000
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102 4 15
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194 2 8 3 12 4 10 5 67 164 20 OECD
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1 1 0.6
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27 2,397 3,000
1. 3 102 2 23
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5.
6.
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27 2,397 3,000
1. 84 1 4 84 1 16 84 10 25.3 98 11.9 53%84 10 11 100 4.1 63% 10
4-5
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27 2,397 3,000 97
1.
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-
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2. 32 102 1 1 32 84 101
3.
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95
97
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4. 99 7 23
99 8 25
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102 3 27 102 6 6
-
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6. 102 7
11 103
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101 (ICH-GCG)(DIA)
: 1. ICH-GCG(International Conference
on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use,ICH 1990
ICH 50 ICH ICH 1999 ICH Global Cooperation Group(GCG) 2 ICH APEC
ICH 2008 ICHDepartment of Health (DoH) ICH-GCG 2 ICH-GCG ICH
2. DIA(Drug Information Association, DIA) 1964
ICH 2012 48
(Integrated Medicinal Product Review Office iMPRO)
6
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1.
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(WSMI)
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5 1 101
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al Scientists
(AAPS)
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81134,4839,00113628,000
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()
102
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1/5(2)
9537095006113995120940037980
-
5
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1/10 (4)
7e
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967102
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614
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(1/3) 1011/5 (85)
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71cGMP1/5 (86)
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cGMP 10295491/10(10) (12)
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(2/3)
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1/20 (14) (16)
329(PM2.5)
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. 102124
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106
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1/5(89)90(20)
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5
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16
1/5(90)(22)
1011122 23
1001/5(91)
100
-
17
1/5(95)
102
1/5(92)
700~800
51,000(23)
102
(1/4)
-
18
1,000(24)
102
(25)
8211011218 10214
2913,000(26)
(2/4)
-
19
1/2(27)
1/5(94)
200(28)
1024101
(3/4)
-
20
1,500(29)64,000
1/2(30)
-1/5(93)1023114
(4/4)
-
21
800(31)
1011210()()77810241
800(32)1011210
(1/2)
-
22
--1/20(33)
1013,76613.1118613993102161,521101162,012491
--1/20(34)
3030
(2/2)
-
23
500(1)
96102710210526
500(2)
5
1/5(5)
1011222 910226
(1/2)
-
24
900 (35)
10227%
500(36)
1.10127599289.24%98101280
2.1027130101(175)26%
(2/2)
-
25
500(37)
269010256%56.524.51146213.5646.27%
500(38)
500(39)
31,5441027810211
-
26
500 (1)
(324)(91)(10181)
500 (2)
90103
500 (3)
3241011222
(1/2)
-
27
1/20 (4)
102 [()(1000)x100%]95%
1/10 (5)
101811010
(2/2)
-
28
-
29
1/5 (8)
(WHO)
250 (1)
50~90%
(1/2)
-
30
500 (2)(3)
1.
2.()()
3.
4.5.6.7.181
(2/2)
-
31
-
32
1/10(1)22()102103
1/10 (2)994
1/10(3)
(1/3)
-
33
1/5 (15)
(ICH,AAPS)MOUMRA
50(4)
500 (5)
(2/3)
-
34
500 (6)
(3/3)
-
35
-
36
()1/10 (1)
42~3
1/10 (2) (3)
10080085,000100101102853
(1/3)
-
37
1/5 (9)
31021
1/5 (10) (11)
1027599.68%99.25%
(2/3)
-
38
(Tw-DRG)1/5(12)
(Tw-DRG)1022
200 (4)
1/5 (13)
1012,23810281,094
(3/3)
-
39
-
40
1/3 (1)
6520182.161024154
2,000 (2)
10112412310222310271
(1/2)
-
41
2,000(3)
33131331
972,000(4)(5)
103-1061023271026610271110310282
(2/2)
-
42
