be2x2.RdIt performs conventional bioequivalence test for 2x2 study. Input is a file. Basic assumption is that the variable is distributed as a log-normal distribution. This is SAS PROC GLM style. If you want PROC MIXED style, use nlme::lme.
be2x2(Data, Columns = c("AUClast", "Cmax", "Tmax"), rtfName="")A data.frame or a csv file name. This should have at least the following columns and variable column(s) to be tested. AUC and Cmax should be all positive values.
GRP : Group or Sequence, 'RT' or 'TR'
PRD : Period, 1 or 2
SUBJ : Subject ID
TRT : Treatment or Drug, 'R' or 'T'
Column names of variables to be tested. This is usaully c("AUClast", "Cmax", "Tmax") or c("AUClast", "AUCinf", "Cmax", "Tmax")
Output filename of rich text format(rtf)
It performs bioequivalency tests for several variables of a 2x2 study in a data file. If you specify output filename in rtfName, the output will be saved in the file.
Returns text output of equivalence test result.
be2x2(NCAResult4BE, c("AUClast", "Cmax", "Tmax"))
#> $AUClast
#> $AUClast$`Analysis of Variance (log scale)`
#> Sum Sq Df Mean Sq F value Pr(>F)
#> SUBJECT 2.8755 32 0.089859 3.1839 0.0008743 ***
#> GROUP 0.1025 1 0.102461 1.1454 0.2927732
#> SUBJECT(GROUP) 2.7730 31 0.089453 3.1695 0.0009544 ***
#> PERIOD 0.0000 1 0.000030 0.0011 0.9740824
#> DRUG 0.0364 1 0.036435 1.2910 0.2645764
#> ERROR 0.8749 31 0.028223
#> TOTAL 3.7868 65
#> ---
#> Signif. codes: 0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1
#>
#> $AUClast$`Between and Within Subject Variability`
#> Between Subject Within Subject
#> Variance Estimate 0.03061507 0.02822265
#> Coefficient of Variation, CV(%) 17.63193968 16.91883011
#>
#> $AUClast$`Least Square Means (geometric mean)`
#> Reference Drug Test Drug
#> Geometric Means 5092.098 4858.245
#>
#> $AUClast$`90% Confidence Interval of Geometric Mean Ratio (T/R)`
#> Lower Limit Point Estimate Upper Limit
#> 90% CI for Ratio 0.889436 0.9540753 1.023412
#>
#> $AUClast$`Sample Size`
#> True Ratio=1 True Ratio=Point Estimate
#> 80% Power Sample Size 6 7
#>
#>
#> $Cmax
#> $Cmax$`Analysis of Variance (log scale)`
#> Sum Sq Df Mean Sq F value Pr(>F)
#> SUBJECT 2.8615 32 0.089422 2.2376 0.01367 *
#> GROUP 0.0001 1 0.000097 0.0011 0.97430
#> SUBJECT(GROUP) 2.8614 31 0.092303 2.3097 0.01132 *
#> PERIOD 0.0047 1 0.004717 0.1180 0.73348
#> DRUG 0.0068 1 0.006838 0.1711 0.68198
#> ERROR 1.2389 31 0.039963
#> TOTAL 4.1123 65
#> ---
#> Signif. codes: 0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1
#>
#> $Cmax$`Between and Within Subject Variability`
#> Between Subject Within Subject
#> Variance Estimate 0.02616997 0.0399631
#> Coefficient of Variation, CV(%) 16.28355371 20.1921690
#>
#> $Cmax$`Least Square Means (geometric mean)`
#> Reference Drug Test Drug
#> Geometric Means 825.5206 808.8778
#>
#> $Cmax$`90% Confidence Interval of Geometric Mean Ratio (T/R)`
#> Lower Limit Point Estimate Upper Limit
#> 90% CI for Ratio 0.9013625 0.9798396 1.065149
#>
#> $Cmax$`Sample Size`
#> True Ratio=1 True Ratio=Point Estimate
#> 80% Power Sample Size 8 8
#>
#>
#> $Tmax
#> $Tmax$`Wilcoxon Signed-Rank Test`
#> p-value
#> 0.2326894
#>
#> $Tmax$`Hodges-Lehmann Estimate`
#> Lower Limit Point Estimate Upper Limit
#> 90% Confidence Interval -0.33000 -0.03500 0.1050
#> 90% Confidence Interval(%) 74.37661 97.28237 108.1529
#>
#>