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: ( - SAS SAS/JMP - WinNonLin - Kinetica - EqivTest - Noramet BioEquiv - Quad One Bioequivalence ):

: - The R Project for Statistical Computing ( - Boomer ( ) - openBUGS

bear, PKfit, ivivc)

:
( ) (Quad One Bioequivalence)

:
/ (SAS, The R Project for Statistical Computing) (SAS/JMP) (WinNonLin, EqivTest, Kinetica, BioEquiv)

SAS
SAS:
proc mixed; Classes seq subj per TRT; model Y = seq per TRT/ DDFM=satterth; random TRT/TYPE = fa0(2) sub = subj G; repeated/GRP = TRT sub = subj; estimate 'T vs. R' TRT 1 -1/cl alpha = 0.1;

R:
a <- 0.05 # alpha theta1 <- 0.90 # lower acceptance limit theta2 <- 1/theta1 # upper acceptance limit ratio <- 0.95 # expected ratio T/R assign("target", c(0.8,0.9)) # target power assign("CV", c(.05,.06,.07,.075,.08, .09,.1,.11,.12,.125, .13,.14,.15,.175,.2,

sep="")) } cat("\n") }

WinNonLin

(2 2)

(Mean, Median, SD, CV%, Geometric mean)

- ANOVA (

( ) Westlake

(2 3, 2 4, 4 2) LLOQ AUC , , IVIVC (f2 f1) in vitro

in vitro /

ANOVA / MANOVA First-order, Hixon Crowell, Higuchi, Weibull, Logistic MDT, MRT, AUC, f1 f2 ( )

:
EqivTest + +

2 2

2=5 2=5

GAMP 5
Winnonlin Validation Suite Of Practice) (ISPE).

GAMP (Good Automated Manufacturing Practice) , COP (Community . ,

!!!

: . . ,

: 1. ( . .) 2. 3. 4. 5. 6. 7. / Cmax, Ae, MRT) (AUC, ( ) ,

: Pharsight Autopilot