..

2510

 ...
.. 2510

 ()
-

-
-


-
-

-




- ,corticosteriod,8


-
-

- ,
, ARVS ,
ABO, ..
- : , Penicillin V 9


1.Dextromethorphan HBr 12 mg.
4 10
2.HCTZ
50 mg. 4
10
3.Ethinylestradiol
0.03-0.05 mg

or Mestranol 0.03-0.05 mg. +
Norgestrel 0.25-0.5 mg.
10
or Levonorgestrel
0.125-0.25

4. CPM
2 mg 4
20
5.Paracetamol 300 - 500 mg +
CPM 1-2 mg
4
10
6. Aminophylline
100 mg
4
7. Theophylline anhydrous 60-150
11


10. Penicillin V Potassium equivalent
to Penicillin V
200,000 units

60
ml

11. Mebendazole 100 mg or

Mebendazole 500 mg per

tablet
6 10
12.Dimenhydrinate 50 mg. 4
10
12
13. Sulphadoxine 500 mg +

-,
, ,
, ,

13

14


1.

2.

3.
4.
15

16

-
-
-
-
17

30

-
18

1.
2.
3.

19

(. 15)
6
(1)
(2)
(3)
(4)

(5)

20


(1)

(2)




21


(1)

(2)


(3)
(4)

22

(5)

(6)

()
()
()


()
(7)

23

(8)

(9) (

)
24

(.25)

(1)
(2)

(3)
(4)

(5) 25

(. 26)
(1)

(2)

(3)

(4)

(5)
26

26


(4)

27

26

28

( 27)
(1)

(2)

(3)

29
(4)

(1)
(2)

(3)
(4)

30

(8)




(9)

(10)

(11)

31
76 (7) (8)

(
46)

( 47)
(1.)

32

(2 )

(3.)

(4.)
33

4

1.
2.
3.

34

1)

2)

3) 35


1.
(.

..)
2.
(. ..
)
3. 36

48 (
)
68 69
70

37

( 57)
1)
2
2)

3)

38

6)

(
54 )
39

( 58)
1) 2

2)

3)
40

(
59)
(1) 2
(2) 41


()
(3)

(4)

42

(1)
(2)

(3)
(4)
(5)

(6)
(7)
43

44
.. 2510


...
( 79)

45


( 79
)

1)

2)
3)
46

1)
2
)

)

2)
47


( 79)

)


)

48

2
1.

2.
49

3
8.1.1

8.1.2
50

51

52

53

(
83)
(1)

(2)

(3)


(4)

54

 (New
Drugs)

(1)
(New chemical entities)
(New derivatives)
(2) (New Indication)
(3)

55

8.2.1

(Original products)
56


(Original products)

2
1.

2.

57



Original products

58


Original products

(1)

(Protocol)

2


59

(3)

60


(Generic products)
3

1.

(Bioequivalence)

61

2.

8.1.1
3.

62

1.

2.



63

3.

4.

64

3
1.

2. 65

66


1.

2.

67

3.1

3.2

3.3

3.4
68

2
)

69

1.

70

71

1.
2.
3.
4.
(Disintegration time)
5.
(Dissolution time)
72



1.
2.
3.

2
1
1
73

- Accreditation overseas suppliers

FDA

74

-

1.
2.

3.

4. 75

11.

( 72)
76

(1)

(2)


(3)

(4)

(5)
77

78

(1)

(2)


79

(1)

(2)

80

( 85 )

81

12.

( 88)
(1)

82

(4)

(5)

(6)

(7)

(8)
83

(9)

(10)
(.90)

( 88 )

(1) (4) (5) (6) (7) (8)

84

88

(1)

85
(2)

-

-

-

86


()
-

-
-
-

-



87


1.

-
-
-
-

-
-

-
-

88

2.
-
-

-

-
3.
-
89