後編PDF - 山形大学医学部
Contents
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5. G CP
6. 1
7. 9
8. 5
9. 2
10. Ts
11. A
12. 6
13. HER 2
14. O PMDA
15. 30 OL
16. 2 Em i fi et pe it nS PMDAMHLW
17. A A De PMDA http www pmda qo jp public_htmWindex html 19 2009 21 12
18. ee net re a cer P ew Be 06 00 EN fe er http Awww info pmda go jp info syounin_index html LT A
19. 1 35 3 5
20. 1
21. 5 ELITE A we LIU a Tes ub CT Ga Eile 8 a 4 3 PMDA
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25. bs 1 2 3 3 4
26. FDA 23 TE LE RE rv 3 1 LLS Li GSU Maw SSS EG 1 PMDA 1 2 ls 4 5 le J 9 2 3 Phase I 1 I 1 gt FDA EMEA 1 gt gt GLP GCP GMP QMS
27. 30 30
28. PMDA PMDA 0 6 2005 3 EE a
29. Academic Science Regulatory Science translation Ee Th ne TL TLT ws nes i i ae a Ep LT 1 nn mn 0 1 1 731 147 12 767 1 1 6 1 1 8 1 4 901 3 1 11 299 64 1 1 3 16 356 18 1995 1999 15 500 900 2004
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32. 0 gt gt FDA EMEA Phase I gt gt II gt HP gt gt PMDA 2009 4 1 mm Harmonization EU 1 1 3rd Summit of Heads of Medicines Regulatory Agencies 3 GHTF 1992 27 3 pec 2008 Sngapore HS 2005 10 2006 1 787 18 7
33. 990 9585 2 2 TEL 023 628 5047 c FAX 023 628 5058 990 0071 5 3 TEL 023 631 2056 6 gt 2 2 2 TEL 023 628 5047 FAX 023 628 5058
34. mm ra 4 1
35. 35 1 2 3 2
36. PMDA Innovation Discovery Pharmaceuticals and Medical Devices Agency PMDA a PMDA vs 2009 7 9 _ gt a 2 _PMDA a 3 PMDA PMDA GLP GCP GMP 1 PMDA MHLW MWS
37. 1 1 1
38. 3 10 9 EE 2
39. Ph LPMDAJ re eee r rmem PMDA EE mn ET 2
40. RF i A i 4 35 2 3 confidential 2000 3
41. 1 1
42. 1 1 2 1
43. W 1 1 Regulatory Science PMDA i
44. 22 2000 4 2001 3 2001 4 2002 3 2005 3 2005 4 2006 3 2006 4 i re Pd tA rt CY 3 5
45. pe LT D 1 PMDA 2 PMDA 3 PMDA Regulatory Science Academic Science ENDAERegulatory Science 12 EE Ea 4 1 PMDA PMDA
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48. 30 23 _ _ 1417 505 915 2004 100 88 1 417 4 8 2004 20 Er Na 3112008 5 INKS UMecycle 0 re 3 I EE ES
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