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!

, , , ,
.

(Dexketoprofen), ,
, 25
101, 103, 105,
()
1
100% 36,9,
25

( -?)

(Dexketoprofen),
,

, 25 101, 103,
105, ()

25 (Dexketoprofen), ,
, 25 101, 103,
105, - /
()
KVR/TAB-FMK 05.08.2015 .
():
04080, . , . ,63

,
10.07.2014, /
220020, ,
. , . , 1031412
.:+375 17 236 40 50; +375 17 236 40 51
: +375 17 236 40 52
-mail: v@marketico.by; amelina@marketico.by


.

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PGE1, PGE2, PGF2,

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(Dexketoprofen),
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.

, ,
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25 . 47% (129 225
).
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4 6 .
15% (38 248 ).

/
.
24 (72)

:
:

t-
;

U-

;

.
() :

(
), 95%
;

(
) 95% ;



95%
.


(
-).


-,
..

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80%.


.

.
,
, , 1842009 (02040)
.
ICH-GCP ( 1842009 (02040) )

(, 2004).

10.

:
1. , ,
:
n=( Z+Z )2( P ( 1P ) )2 /D 2
2. , :
n=( Z+Z )22 Sx 2 /2
: n , ;
Z = 1,96;
Z = 0,84; D ; P
; ;Sx
;


(
15 ).
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,
30 .
60
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. 60
80%,
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2 .

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p<0,05. (1)
80%.

1. Ryan Thomas P., Sample Size Determination and Power. John Wiley & Sons,
Inc., 2013, p. 378.
2. Chow Shein-Chung, Wang Hansheng, Shao Jun. Sample Size Calculations in
Clinical Research. 2nd ed., Chapman &Hall/CRC, 2007, p. 359.
3. Walters Stephen J. Sample size and power estimation for studies with health
related quality of life outcomes: a comparison of four methods using the SF36. Health and Quality of Life Outcomes 2004, 2:26.
4. Lwanga S.K., Lemeshow S. Sample size determination in health studies. WHO,
1991, p. 80.

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