1
---- ---- 2
NCE
3
4
5
1
()
//
2
///
A
a API
--
(iv)(ip)(po)(sc)(ig) b
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c
LD50
Note: LD5096h50%ED50LD50/ED50 d
e
12
f
S9
2 2
NIH----()
1
60-80d14d 2
6-15d 6-15d6-18d20d
1/21/2 3
21d28d31d
1 2 1
2
ADMEabsorptiondistributionmetabolismexcretion
1 2 3
4 5 1 2
t1/2()t1/2()K12K10Vd CLAUCAUC:AreaUnderCurve Kat1/2CLVdCmaxTmaxAUC
IIIIIIIIFDA
IND SFDA(
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, (NDA) SFDA(FDA SFDA(FDA
IV
Adverse drug reaction, ADR)
15SFDA(FDA
(SFDA)
1; 2; 3;
4;
5; 6; 7; 8; 9; 10; 11
1
1
2 3 4; 5
2; 3 1 2
3 4 5
6
1.
2.
3. 4.
5. 6.
7. 8.
9.
10.
11.DNA 12. 13.
14.12 15.
1-11-2
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Randomized Controlled Open Labeled Clinical Trial
IV IV SDA>2000
3-6
