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- みさき みょうだに
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5 3- {a-[(^9)-2-hydroxy-3'(2-morpholirocarbonylamino) ethylaminolprnpoxy I phenylpropionate monohydrnchloride
6
7
8
9
10
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12 (!s/ml) a m El t) >1! 0 (mllmin) CR/F
13 Cmax (rrolml)
14 p= OOmg l5orngiln X li3oomg O,127nl
15
16
17 U rt )vrf'v ff5omg
18
19 (ne/ml)cmax 4?mg 56mg 6.461= I %
20
21 Tastellas BOnOtrgO%abrerssomg
22
23 Cmax 6c/mL) Cmax Tmax (nglml) (h)
24
25
26 Page I
27
28 Page 3 I lel600 rng l E3Fl
29 Page 4, ^jfltr E'7iB
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31 Page 6
32 Page m8/et ms/ F fif
33
34 Page 9
35 Page 10
36
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38 Page 13
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40 Page 15 l?00ngef,f 1800ms/EFf
41
42 Page 17
43 600 mg 200 mg 400 mg 800 mg 400 mg 400 mg 400 mg 600 mg
44
45 x *+* xc!.t//r)>7 tu:1-tt 10. CaE
46 ,bu s l,tqfi
47
48
49
50 L0?;*i
51 Tnnx ftr) tuax (ng,hl) tr,'? ftr) IUC(ng'hr/nl,) CLi F ft,/ln)
52 85.7al,G/7) 5r,49i,(lB/35)
53
54 =-\r:fe00mc
55
56
57
58 AUC,t-r!eh (ng'hr,/ml) 8004) 1000q)
59
60
61
62 2007+t2E
63
64 I{2*E{FffiffrAtl 7 :-f t>
65
66 r4623 (48) r 023 (3 r) 28. 3yo (ri\/46fr))
67
68 @o:,'nv-z
69
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71 mcanas. D.
72 l0mg mean-s. D- r,' s ml ) --.-lj.th TVtl mcants. D.
73 &?ijj (meanls. D. ) ft+fit lmea.ts, D. )
74
75
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77 tona /l -,o.8rl
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80
81
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83 s8%s (r2t/2o8 FJ) l4%(t2187 Et)) 44o/"\ (41t9l FrJ) 40 mg+1 u
84 36y,e (27/76 Frl) (34ns9 Ftl) 61j) t2% (20 10 N) 36"/" s (62l17: F{)
85
86
87 Page 1 ZlfHRAlAe lntravenous use HffffiltE7t^tr v.( r>^7fr1h
88 Page 2
89 Page 3
90 Page 4 Itn E o-ro orl Cmax G9lnl-) X1 : n=9
91 Page 5
92 Page 6
93 Page 7
94 Velaglucerase alfa Shire Human Genetic Therapies, Inc,
95
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