1 - アストラゼネカ
Contents
1. p 9 p 352. 4ug kg 7ug kg 200 000 g kg 6 16 171 g kg 60 208 g kg 1 18 169 g kg 18 227ug kg 6
3. 39
4. S mm HH 2 13 p 5 9 1 1 2 2 93 9 92 2 p lt 0 001 9 92 10 8 4 2 93 2 1 12 n 60 n 60
5. 8 9 10
6. 1 3 4 0 25mg 26mLX30 1 5 X6
7. WG 6
8. 23 0 CS 9
9. 5026 HH S0926 HH pH pH 60 HH 40 RH Te0hlux hr 200Wh m 90 pH pH pH pH
10. 32 38 32 33 F 4 1 200 400 g 1 3 CD 1 9 1 SD 104 Fischer 1104 SD
11. 1 0 255mg 0 5mg Nb 2mL 80 0 25mg 0 5mg 51mm 51mm 10mm 10mm 1 Budesonide JAN 5 16 17o butylidenedioxy 11 21 dihydroxy 1 4 pregnadiene 3 20 dione O gt CHzCHezCHs O
12. 1 990 010 4 85 DPI DOMDI 0 4 1
13. 6 8 9 1 1 3 1
14. 4 5 6
15. 7 12 7 3 7 SI 15 3 2 24
16. 7 N 22 RNNSYI 23 1 1 mg 1 5 40 1 0mg 1 5 n 2 nmol L 2 0 sp 1 5 1 0 0 5 0 0 2 4 6 8 10 12 AUC Cmax Tmax t1 2 allllgla74 allllgl4 min h 1 0mg 1 0mg 1 65 4 4 65 0 1 35 100 8 8 1 12 8 3 96 44 3 400 g 5 36 54 5 1 71 80 8 18 7 13 9 4 00 3
17. UOI1BUJJO U nud UOIHBUUJOJU nd Drug Information 1 1 1 8 4 6 3
18. 3 3 10 1 6 4 6 1 86 9 1 4 896 6 9 89 4 1 1 62 6 1 14 1 1
19. pH 80lux 1 0 Iux hr 200Wh me pH pH 0 25mg 0 5mg 1 4 4 48 34 Sr HH x d 35 1 1
20. 8 8 4 0
21. 3 in vitro 12 15 3H 100 g 16C MI 6 MI 196 3 P450 CYPSA4 5 O M C CHsOH C CHzOH a O ll O C CHzOH O mk T MI CR 16o 21 OH 9 CC ON 0 We 0 5 HO SC 2 O we 9 Q gt ox CH2CH2CHs O O 23 C CHzOH HO O Il C CHzOH OT lt Cn ls HO 0 C O 68 O
22. 6 096 1896 496 9 1 45 mg Pari LC Jet Plus 5096 9 Dose to Subject DTS 7 1 45 2mg Pari LC Jet Plus 1396 9 10 G 6 1 mg Pari LC Jet Plus 696 9 3 6 10 8096 496
23. 105 15 14 3 5 4 89 6 1 99 2 8 1554 164 10 69 44 2 896 16 1 09 14 0 99 1 1 0 79 CIE 6 1 7 9 1 1 696 2 3 39 3 4 996 1 1 69 1 1 696 6 5 61 1493 1554 1
24. 6 5 2006 9 859 65 QOL 5 pMDI DPI 2010 1 1 1
25. 30 25 5 25 20 15 9 3 0 24 n 60 n 54 1 9 1 6 5 6O 0 25mg 1 5 0 5mg 1 1 24 6 1 0mg 6 1 9 1 1 6 3 3 3 4 9
26. SD SD 4 Maximization test PCA 5 in vitro O 8 885w N 39 24
27. Churg Straus8 Churg StrausS 11 18 4 3
28. 2 22 BALF BALF 29 Sephadex 4 FE 10mg kg
29. 3 5 CO 4 1 9 7 47ug kg 2 1 g kg 3 0 2 2 20ug kg a 6 3 1 g kg 3 g kg 2 BTL TLE KE lt 1 8 g kg 3 5 6 6 40 g kg 5 g kg 3 0 500 g kg 2 1315 g kg G7 540 g kg 1 3
30. 4 2mg 1mg 6 4 lt Ei i 400ug1l 2 1 0mg 1 2 4 0 4 6 10 c 800 g 400 g 400 g 00 g 1 1 1
31. 1 3 II ug mL 2 2020 0 WB 1 gt 5 SI A ND 26 3O lt _ NN 28 29 E 3
32. 6 SABA 17 SABA 3 SD 0 196 0 436 0 152 0 339 0 242 0 515 0 043 0 145 OU TELU TUG DO68 0 1 0 043 0 168 Ue ee UU2ITU U7Y 6 SD 0 36 0 5 0 1 70 0 434 SUSTEI b88 0 104 0 373 0 04 0 59 0 163 0 45 OU3YEO TS7 0 0 0 14 0 051 0 1 0 SD 9596CD 0 039 0 346 0 028 0 018 0 3384 0 075 0 06 0 360 0 038 0 061 0 317 0 000 0 058 0 244 0 038 0 0984 0 376 0 010 0 004 0 165 USEU 1 98 0 0 1g 0 106 0 110 0 16 0 1 0 096 0 1998 0 088 0 018 0 069 a 14 b
33. 4 387 7L 6 391 0 L 3 GL HH SWIIIO L lt Mean SE ml 1 T T 400 380 a 2 360 1 340 320 300 2 4 5 6 5 LOCF n 105 105 102 101 105 n 53 53 53 53 53 n 52 52 49 48 52 LOCF Last Observation Carried Forward a 14 b 14 1 6 FEV1 60 105
34. 6 1 9 1 1 6 3 39 3 4 996 1 696 1 1 696 59 196 2 1 2 UOI1BUJJO U nud UOIHBUUJOJU 8nJ Drug Information 5 6
35. IAR LAR 21 22 31 3096 ANOVA 3 15 596 pD 0 05 in vitro 29 GM CSF
36. 14 SABA short acting se agOnist z 1 5 4 7 3 E 2 1 0 31 72 12 0 5mg 1 2 1 1 gt 18
37. 8 11 ACTH 0 25mg or 60 18 g dL 10 g dL 300 1 168 cm cm 130 130 120 120 110 110 100 100 90 90 80 80 70 70 60 60 50 50 40 6 5 53 0 35mg 1 5 0 5mg 1 1 6 i 1 0mg 24 0 5mg 1 0 5mg 1 0mg 1 168 i 50 97 i 2 2
38. CsHs40e 430 53 540 C 95 0 5mg 1 1mg 1 1 1 Gmg 0 25mg 1 5 0 5mg 1 1 1 1 mg gt 1 2
39. 1995 12 1984 13 Dahlberg E et al Mol Pharmacol 25 70 78 1984 14 Jonsson G et al Drug Metab Dispos 23 137 142 1995 15 Edsbacker S et al Drug Metab Dispos 15 403 411 1987 16 Seidegard J Clin Pharmacol Ther 68 13 1 7 2000 17 Raaska K et al Clin Pharmacol Ther 72 3G62 369 2002 18 19 6 153 162 2007 20 Linden M et al Pulm Pharmacol 7 43 47 1994 21 Woolley MJ et al J Appl Physiol 77 1303 1308 1994 D 1995 23 Svensjo E et al Prog Resp Res 19 173 180 1985 24 Brattsand R et al Proceedings from a Symposium in Basel Excerpta Medica 145 153 1984 25 Edsbacker S Basic Clin Pharmacol Toxicol 98 523 536 2006 26 Edsbacker S et al Ann Allergy Asthma Immunol 88 609 616 2002 27 Brattsand R et al Clin Ther 25 C28 C41 2003 28 Wieslander E et al Am J Respir Cell Mol Biol 19 477 484 1998 29 Miller Larsson A et al Drug Metab Dispos 26 623 630 1998 30 Miller Larsson A et al Am J Respir Crit Care Med 162 1455 1461 2000 31 Abraham WM et
40. 48 92 3 3 39 DD 2015 1 9 4 O
41. 867 9 Astrazeneca 2 Product Inftormation LL 38w Pulmicort RespuleS 6sss 1 2 CONTENTS 1 3 5 5 6 6 6 7 10 13 13 1 13 14 3
42. 144 0 A B 0 12 24 24 48 72 96 120 144 n 59 n 59 n 60 n 53 n 52 n 49 n 37 n 29 n 23 i 6 5 60 A 0 35mg 1 5 0 5mg 1 1 24 6 1 0mg B 4 0 25mg 1 0 5mg 1 0mg 1 i 1 24 48 72 86 120 144 i 5 g dL 9 ACTH A B C D E F G H ug dL g dL 6 US RS 5 38 SR 4 06
43. 0 4 59 10 14 10 7 000 6 000 5 000 3 4000 2 3000 2 000 1 000 1987 1990 1993 1996 1999 2002 2005 65 8 000 7 000 6 000 5 000 4 000 3 000 2 000 1 000 65 90 4 a 85 e 80 J 75 70 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 16 896 8008 IN ET 8 p 5 9 p 19 20 UOIHBUUJOJU nd Drug Information 1
44. BDP 1 7 3 8 17 5 17 4 0 001 0 01 0 001mg kg TTY 30 31 1 3 LDso mg kg mn 6S IS 100 gt 100 gt 100 EA 68 gt 6g 1 1 3 4 6 3
45. 696 a Ry 100 8096 WS 40 J LJ ii 1596 139 NL 0 5 50 0 019 12 19 44 0 5mg 1 1L JET 10 3 6 125 g 1L kKg 24 25 rs E in o 909 3H
46. 0 008 0 0 1 0 01mg kg K 0 03 0 1 1 10 0 03 10mg kg 1 6mg kg 10 15 le BDP 1 10 8 500 ng cm BDP BV 12 18 05 lt 3125 ug cm BDP 1 8 BV BDP 2 G6 200 EI 10 Wg 1 100 ug BDP 1 1 7 3 8 BDP 5 320 ug
47. 0 155 5 50 30 2 3 1 12 4 1 gt i LL 8 1 9
48. 1 6 12 12 18 18 6 3 8 5 60 0 25mg1 5 0 5mg 1 1 24 6 0mg 1 4 12 0 5 1 0mg 10 1 1 n 28 mt 1 1 1 2 n 60 8 p 0 001 vs baseline 4 2 0 8 0 2 4 6 8 10 12 1
49. CYP3A4 CYP3A4 CYP3A4 4 4 105 15 14 3 5 4 8 1 996 2 8 1554 164 10 69 44 89 16 1 096 14 0 8 1 1 0 79
50. 0 5mg 2mLX30 1 5 X6 0 25mg 21800AMY10113 0 5mg 1800AMY10114 2006 1981 10 2006 9 2006 9 2010 7 dih 19 273 287 2005 3 17 1876 1890 2010 4 Marcus P Journal of Applied Research 9 1 amp 2 2 13 2009 5 6 22 116 1258 2008 Murphy K et al Clinical Therapeutics 29 1013 1026 2007 8 Agertoft L et al Arch Dis Child 80 241 247 1999 9 2010 10 Dahlstrom K et al Ann Allergy Asthma Immunol 90 226 232 2003 11
51. 14 396 15 105 5 4 896 1 996 HF Hl gt 2S 3 4 6 7 III gt L 440 420 400 380 I 360 340 320 300 2 65 n 91 65 n 14 2 5 4 5 91 88 14 14 LOCF Last Observation Carried Forward a 14 b 14 6 87 14 Mean SE 0 65 65 LOCF 91 14 3
52. 1 1 69 1 EVO OS 12 1 1 3
53. ALT GPT 21 g kg 37 g kg 200 6 000 g kg 1 17 180 g kg 1 25 g kg 6 52 g kg 67 g kg Le 3 885w 3 5 50 g kg 4 35 g kg 65 g kg 1
54. K UNIOMI0 20000 NR 0 IS INS UE K 1 5 N 930 A 6 gt A N 2 5 2 22 5 A 180 E N Ni 2 11 N 2 8 5 5 ha 30 0 3 3 6 6 9 9 12 12 15 20 Nl ff i lll ol i FUE FT EI NN IN NT 000 EE EE EE 0 0 0 i 2 CC CC IIOIUIOON0OSII 0 0 SU IN SS K ii N 930 A 6 I A N Z 2 5 180 E N 2 11 N 2 8 5 5 0 5mg 2 0mL 25 1 mL i 3 1 3
55. 2 GT TO iM mvito 106 105 104 104g mL 1 3 K 5 nvio 10S 105 104 104g mL 8 5 5 1096 RA ON invito 108 105 104 104g mL 4 5 3 179 7 ILLN v a in vitro nvito 106 105 1034 104g mL 9 3396 10mg kg 4 5 0 1 1 10 15 120 91 1 10 1mg kg 15 8 2 NN 10mg kg 120 EL 9 0 1mg kg 9 1 1 10 1 10mg kg pH OS 10 10 g mL Xs NN lt ShaSL 89 lk 1 10 0 1 10mg kg
56. 12 6 1 12 Al PP 200ug 16 18ug kg 18 20ug kg 3 FDA
57. O 10 4g mL pH 2 33 n mg kg g mD 10mg kg
58. O O 1 O 1 1 O 1 O O O 1 0 1 0 3 8 I a RD 0 0 0 0 1 6 O 1 O 1 O O O O 1 0 O O O O 1 1 O 1 O O O 1 O 1 0 O O 1 O 1 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 0 O O 1 O 1 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O 1 0 O O 1 O 1 1 O 1 O O O 1 O 1 O O O O 1 O 1 O O O 0 O O O 1 1 O 1 O O O O 1 19 O N iL 6 6 5 9 9 9 9 9 3 0 O O 0 1 2 3 0 5 0 O O O 1 O 1 O O O O 1 O 0 O O O 1 1 0 O 1 CER 0 O O 0 O O O 2 O 1 0 O O O 1 O O O 1 O 1 O O O O 1 1 O O O 1 O 1 O 0 O O 0 O O O O O 1 1 0 1 O 1 O O O 1 O 1 1 0 1
59. 1 O O O O 1 0 O O ND O O O O 1 1 O 1 O O O 1 O 1 O 0 O O O O O O O O 1 1 0 1 O 1 O 1 O O O 1 O 1 ND O O O 1 TT OQ 1 0 O 0 O13 O 1 O O O 1 O 1 O 1 O O O 1 O 1 O 0 EO OQ 1 O O 1 1 0 1 O 1 6 0 24 4 4 48 72 7 96 n 6 1 n 6 1 4 n 54 n 51 1 1 6 1 1 6 0 9 9 CTE BS 3 4 9 MS 1 1 8 1 1 8 0 11 5 1 1 6 0 0 1 1 1 7 3 7 21 1
60. 15 16 16 17 3 17 4 18 19 19 21 1 21 22 23 1 23 24 9 25 4 25 5 25 56 26 28 28 1 28 29 30 31 1 31 31 3 32 4 33 34 34 35 36 DP 2002 2010 7
61. O O O 1 O 1 0 0 O O O 1 O O O a O 1 O O O DD O O O O 1 O 0 O O 1 O 1 1 O 1 O O O 1 O 1 O O O O 1 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 0 O O 1 O 1 1 O 1 O O O 1 O 1 0 0 0 0 1 O 1 0 0 0 O 1 0 O O 2 0 5 7 0 5 O O O O 4 0 O O 5 O 3 5 GD O O O 5 O 3 O O O O 1 1 O 1 O O O 1 O 1 0 O O 1 O 1 1 O 1 O O O 1 O 1 0 OO 6 OD 6 AD 0 O 0 6 0 4 0 0O 0 0 1 0 1 0 0 0 2 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 0 O O OD 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 0 O O O 1 1 O 1 O O O 1 O 1 0 O O O 1 1 O 1 O O O 1 O 1 0 O O 3 WD 3 TD O O O 3 2 O O O 1 O 1 1 O 1 O O O 1 O 1 0 O O OD 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 O 00 O 1 1 O 1 O O O 1 O 1 O 0 GO 3 ED 3 CD O O O 3 TD 0 O O 2 O 1 O 1 O O O O
62. a 22 30120 0 CE Do nN 5 Bo 2 2 6 6 1 N 0 90 2 S N NM p NN 6 U S 5 i 26 i 1 mL i 9 European 500 5 Committee for Standardization Standard 1 IR C 26 K 27 5 19 O eoWNN 35 30 0 3 3 6 6 9 9 12 12 15 2 25 20 15 il li 1 lj i i NN N NN 0 7 ON NN 2 2 CC
63. 0 6 1 AUC Cmax t 2 96CV Tmax SD ULC 9 10 3 6 1 mg AUC 4 6nmol h L 3 1 8 9 10 3 6 1mg Pari LC Jet Plus 409 6
64. 05 1659 9 9 3 O 0 0 44 9 44 G8 1 1 0 45 O O O 5 0 3 5 0 3 0 O O 5 O 8 O O O 5 0 3 5 0 3 0 0 0 5 0 3 O O O O 1 O 1 O O O O 1 O 0 0 2 O 1 O 1 O 0 0 2 O 1 O O O O 1 O 1 O O O O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 O O O 1 O 1 O 1 O O O 1 O 1 0 O O O 1 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O 1 O O O 1 O 1 O O O O 1 O 1 O O O 1 O 1 0 O O 1 O 1 O 1 O O O 1 O 1 O O O 1 O 1 1 O O 1 O 1 O DO EE 9 DE a 0 O O 11 0 7 11 0 7 2 1 9 13 O8 0 O O 0 G2 10 O6 O O O 10 O6 0 O O 9 O 6 9 O 6 1 1 0 10 O6 0 0 O O 4 O 8 4 O 8 O O O 4 0 2 0 O O O 1 O 1 1 O 1 O O O 1 O 1 0 0 ODE ET 2 Dn Ea 0 O
65. 4 3H 100 g 96 579 G496 5 6 1 3mg 200mg AUC 6 8 9 1 000 g 200mg AUC 4 8 2 4 6 in O 9 40 0 3 1 3 6 6 9 9 12 12 15 30 R20 ERS ZINIINNIINI 2 2202 SI M 0 NE BI 2 II 0 2 FE i CC lt p UE SN
66. 4 16 18 20 22 24 Paired t 1 6 12 12 18 18 6 3 8 5 60 0 25mg 1 5 0 5mg 1 1 24 6 1 0mg 6 1 9 1 1 6 3 3 3 4 9 1 1 69 1 11896 SS
67. al Bull Eur Physiopathol Respir 22 387 392 1986 32 O Riordan TG et al Am J Respir Crit Care Med 155 A878 1997 33 34 35 36 37 19 10 5093 1985 38 Kihlstrom 1 Arzneimitte Forschung Drug Research 37 1 43 46 1987 39 36 Astrazenecs 3 1 gg0120 189 115 RES001 B AZ01 2015 1
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