Description Usage Arguments Details Value Author(s) Examples
It performs conventional bioequivalence test for 2x2 study. 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
.
1 | test2x2(bedata, Var)
|
bedata |
Data table name. This should have at least the following columns and a variable column to be tested. GRP : Group or Sequence, 'RT' or 'TR' PRD : Period, 1 or 2 SUBJ : Subject ID TRT : Treatment or Drug, 'R' or 'T' |
Var |
Variable to be tested. This should be one of the column names in |
It tests Var
variable equivalency from a 2x2 study. Current regulatory requirement is that the 90% confidence interval of geometric mean ratio (Test/Reference) should be within [0.8, 1.25].
Analysis of Variance (log scale) |
Analysis of Variance in log scale |
Between and Within Subject Variability |
Variance in log scale and coefficient of variance in original scale |
Least Square Means |
Geometric means |
90% Confidence Interval |
90% confidence interval of geometric mean ratio (T/R) |
Sample Size |
Sample size for the replication of this study |
Kyun-Seop Bae k@acr.kr
1 2 | test2x2(NCAResult4BE, "AUClast")
test2x2(NCAResult4BE, "Cmax")
|
Loading required package: rtf
$`Analysis of Variance (log scale)`
Df Sum Sq Mean Sq F value Pr(>F)
SUBJECT 32 2.8755 0.089859 3.1839 0.0008743 ***
GROUP 1 0.1025 0.102461 1.1454 0.2927732
SUBJECT(GROUP) 31 2.7730 0.089453 3.1695 0.0009544 ***
PERIOD 1 0.0000 0.000030 0.0011 0.9740824
DRUG 1 0.0364 0.036435 1.2910 0.2645764
ERROR 31 0.8749 0.028223
TOTAL 65 3.7868
---
Signif. codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘.’ 0.1 ‘ ’ 1
$`Between and Within Subject Variability`
Between Subject Within Subject
Variance Estimate 0.03061507 0.02822265
Coefficient of Variation, CV(%) 17.63193968 16.91883011
$`Least Square Means (geometric mean)`
Reference Drug Test Drug
Geometric Means 5092.098 4858.245
$`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
$`Sample Size`
True Ratio=1 True Ratio=Point Estimate
80% Power Sample Size 6 7
$`Analysis of Variance (log scale)`
Df Sum Sq Mean Sq F value Pr(>F)
SUBJECT 32 2.8615 0.089422 2.2376 0.01367 *
GROUP 1 0.0001 0.000097 0.0011 0.97430
SUBJECT(GROUP) 31 2.8614 0.092303 2.3097 0.01132 *
PERIOD 1 0.0047 0.004717 0.1180 0.73348
DRUG 1 0.0068 0.006838 0.1711 0.68198
ERROR 31 1.2389 0.039963
TOTAL 65 4.1123
---
Signif. codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘.’ 0.1 ‘ ’ 1
$`Between and Within Subject Variability`
Between Subject Within Subject
Variance Estimate 0.02616997 0.0399631
Coefficient of Variation, CV(%) 16.28355371 20.1921690
$`Least Square Means (geometric mean)`
Reference Drug Test Drug
Geometric Means 825.5206 808.8778
$`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
$`Sample Size`
True Ratio=1 True Ratio=Point Estimate
80% Power Sample Size 8 8
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