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53. ~ : , , . , , 5 ....
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54. ~ .
|
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55. ~ .
|
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56. ~ .
|
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|
57. ~ .
|
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|
, .
|
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|
- , .
|
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- , .
|
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, .
|
|0,1
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62. ~ .
|
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63. ~ .
|
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|
, , , , , .
|
|
|
|Food and Drug Administration (FDA)
|Good Participation Practice (GPP)
|International conference of harmonization (ICH)
|European Medicines Agency (EMEA)
|Good Manufacturing Practice (GMP)
65. ~ ICH .
|Q10
|M4
|E5
|Q1
|Q9
66. ~ ICH .
|Q2(R1)
|Q3C(R3)
|Q3B(R2)
|Q3A(R2)
|Q1A(R2)
67. ~ ICH Q2(R1) .
|
|
|
|GMP
| ,
68. ~ ICH .
|E2A
|E2B(R3)
|E2E
|E2D
|E2C(R1)
69. ~ , , .
| GLP
|
|
|
| GVP
70. ~ ICH .
|Q1
|Q2
|Q8
|Q9
|Q4
71. ~ ICH :
|, ,
|,
|, ,
|,
|
72. ~ ICH :
|The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
|European Union (EU)
| Pharmaceutical Research and Manufacturers of America (PhRMA)
|World Health Organization (WHO)
|Food and Drug Administration, USA (FDA)
73. ~ICH .
| -,
| (Observers), IFPMA
| (ICH Parties) (Observers)
| (ICH Parties), (Observers) IFPMA
| , EFTA
74. ~ ICH .
| E5
|M4
| Q8
|Q9
|9
75. ~ ICH GCP .
|E2B(R3)
|E2A
|E6(R1)
|E2D
|E2C(R1)
76. ~ ICH S2B .
|
|
|
|GMP
|
77. ~ ICH .
|1B
|E2A
|S2B
|S1A
|Q3A
78. ~ ICH M1 .
| ()
|
|
|
|
