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in vitro



!

:
FDA ():
Waiver of In Vivo Bioavailability and Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based on a Biopharmaceutics Classification
System 08/2000
EMEA ():
Note for guidance on the investigation of bioavailability and
bioequivalence /EWP/QWP/1401/98 26/07/2001
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (DRAFT)
CPMP/EWP/QWP/1401/98 Rev. 1 24.07.2008
FIP:

WHO:
WHO Technical Report Series 937
WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL
PREPARATIONS, Fortieth Report, 2006
+ 2 ():
190

17.04.2007

:
FDA:
http://www.fda.gov/cder/guidance/3618fnl.pdf
EMEA:
http://www.emea.europa.eu/pdfs/human/ewp/140198en.pdf
http://www.emea.europa.eu/pdfs/human/qwp/140198enrev1.pdf
FIP:
http://www.fip.org/www/index.php?page=ps_sig_bcs
WHO:
http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf
:
http://www.pharma-center.kiev.ua/view/new_doc


1.


2. in vivo
( in vivo
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4.

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EMEA

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(100 rpm) (100 rpm) (100 rpm)

900

500

900 500

37 0,5

37 0,5

370,5

1. 0,1N HCl SGF 1. 0,1N HCl SGF 1. 0,1N HCl


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SIF (
SIF (
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)

1 7,5

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10, 15, 20,30

10, 15, 20, 30,45

10, 15, 20, 30,45

pH 1.2-2.1


pH 4.4-6.6


pH 6.5-7.5

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EMEA
1

WHO
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ANOVA / MANOVA
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MDT, MRT, AUC, f1 f2 ( )

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1.
2.
3.
4.
5.
6.
7.
8.

The R Project for Statistical Computing


S-Plus
SPSS
SAS
WinNonLin
Kinetica
EquivTest



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