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1 CTD mg 0.4mg 0.6mg 0.8mg 1.0mg 1.2mg 1.4mg 1.6mg 1.8mg 2.0mg 12mg
2
3 2.6 Page
4 2.6 Page 4
5 2.6.6 Page AGHD AUC 0-24h Cmax F 0 F 1 GH IGF-I IU PCA 24 1 I IU IU mg 1 mg = 3 IU
6 Page AGHD 12 OECD FDA GLP mg IU /kg/day 52 IGF-I 0.13mg/kg/day 0.65 mg/kg/day 0.65 mg/kg/day 3.23 mg/kg/day 3.23 mg/kg/day 3.23 mg/kg/day mg/kg/day GH mg/kg/day 0.65 mg/kg/day AUC 0-24h 2.66 µg (8.22 miu) h/ml 2.32 µg (7.19 miu) h/ml 1 AGHD 0.04 IU/kg/day mg/kg/day 75 kg 1 mg/body/day AUC 0-24h ng h/ml mg/body/day 0.05 mg/kg/day IU/kg IU/kg IU/kg 16 IU/kg GH mg (1.7 IU)/kg/day
7 Page mg (8.4 IU)/kg/day mg (0.34 IU)/kg/day 3 1 IU/kg/day mg (0.33 IU)/kg/day mg (8.33 IU)/kg/day mg (0.33 IU)/kg/day Ames L5178Y GH 2 ng/iu F0 3 IU/kg 10 IU/kg F1 3 IU/kg 1 IU/kg 3 IU/kg 10 IU/kg IU/kg F1 10 IU/kg 1 IU/kg 4 IU/kg
8 Page IU/kg 1 IU/kg F0 F1 10 IU/kg F1 3 IU/kg GH PCA
9 Page p p mg (8.33 IU)/kg/day mg (10 IU)/kg/day 0.13 mg (0.4 IU)/kg/day mg/kg/week mg/kg/day mg (2 IU)/kg/day mg/kg/day mg/kg/day IGF-I 0.13mg/kg/day 0.65 mg/kg/day 0.65 mg/kg/day 3.23 mg/kg/day GH
10 Page mg/kg/day 3.23 mg/kg/day 0.65 mg/kg/day 3.23 mg/kg/day 3.23 mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day GH 3.23 mg/kg/day mg/kg/day 0.65 mg/kg/day AUC 0-24h 2.66 µg (8.22 miu) h/ml 2.32 µg (7.19 miu) h/ml 1 AGHD 0.04 IU/kg/day mg/kg/day 75 kg 1 mg/body/day AUC 0-24h ng h/ml 1) 23 20
11 Page p Ames L5178Y p GH 2 ng/iu p p p p p
12 Page GH 12 IGF-I GH IGF-I GH GH GH 3.23 mg/kg/day GH 3.23 mg/kg/day 1 AUC 0-24h ng h/ml ng h/ml AGHD AUC 0-24h ng h/ml 1) mg/kg/day 0.65 mg/kg/day 12 3 GH 12
13 Page mg/kg/day AUC 0-24h AGHD 1 mg/body/day GH 20 23
14 Page 14 1) SM , , 1997
15
16 mg/kg GLP 52 0, 0.13, 0.65, 3.23 GLP XFI Page 16
17 ) mg/kg AUC 0-24h (ng h/ml) 2) AUC 0-24h (ng h/ml) ) ) ) Page 17
18
19 2.6.7 Page
20
21 (mg/kg/day) M: 7 F: 7 M: 5 F: 5 M: 5 F: 5 M: 7 F: 7 52 ng/ml b) * 3.0* µiu/ml b) 95* 145* a) ng/ml 1 ND 446 ND 448 ND 227 ND 61* 4 ND 267 ND 263 ND 309 ND 64 7 ND 334 ND 577 ND 108 ND ND 335 ND 609 ND 585 ND 77 IGF-I ng/ml * b) * 1152* 1932* 926* ml/min * *p<0.05 Dunnett Wilcoxon a) b) n=4 ND Page 21
22 (mg/kg/day) M: 7 F: 7 M: 5 F: 5 M: 5 F: 5 M: 7 F: b) ND ND ND ND ml c) ND b) ND 11.04* ND ND a) ND 5 ND 1 ND 1 ND 13 ND 0 ND 0 ND 1 ND 2 GH 1 d) e) 0 ND a) b) n=4 c) n=6 d) 52 e) 26 *p<0.05 Dunnett Wilcoxon Page 22
23 (mg/kg/day) M: 7 F: 7 M: 5 F: 5 M: 5 F: 5 M: 7 F: ND ND ND ND ND ND ND ND 1 a) ND ND ND ND 1 a) ND ND ND ND 1 a) 1 ND a) n= Page 23
24 2.6.7 Page In Vitro In Vivo
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66 22 g 13 g 8 g 5 g 7500 IU 150% 300 mg 600 IU 100 IU 80 mcg 3 mg 3.5 mg 40 mg 4 mg 500 mcg 12 mcg 300 mcg 20 mg 1000 mg 150 mcg 400 mg 15 mg 105 mcg 2 mg 2 mg 180 mcg 125 mcg 15 mg 3.6 g ** 3.8 g **
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1 10 4 2 92 11 3 8 20 10 2 10 20 10 28 3 B 78 111 104 1021 95 10 2 4 10 8 95 18 10 30 11 13 104 20 105 105 105 105 107 5 1 11 26 13301500 6 GH 1 GH 34 7 11 27 9301030 8 4 9 GH 1 23 10 20 60 --------------------------------------------------------------------------------------------------------------------------
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5.3mg () 1 2SD 2 1.5SD 17 15 2 4 4 3 ( ) 瘙 3 嘔 気 嘔 吐 腹 痛 消 化 不 良 便 秘 4 24 p * p ** IGF-I (ng/ml) 77.12±60.19 238.97±143.60 161.85±113.30 [124.08, 199.63] (p
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(1) / 130 g 25 g 520% 170 g 30 g 560% 70 mg 600 mg 11.6% 0 10.5 mg 0% (1) (2) / 50100 g 25 g 200400% 50100 g 30 g 167333% 5001000 mg 600 mg 83167% 1020 mg 10.5 mg 95190% (2) / (1) 45.6 g 30 g 152% (2)
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2012 4 5 873112 2008 () 1 0.5g 0.5g 0.75g 0.75g JAN EldecalcitolJAN 2011 1 21 2011 3 11 2011 4 11 TEL0120-591-818 03-3985-5599 8:3017:00 http://www.taishotoyama.co.jp/ 20124 http://www.info.pmda.go.jp/
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