TRR.RTR {replicateBE} | R Documentation |
Reference Dataset for TRR|RTR (extra-reference) Designs
Description
Dataset simulated to be evaluated by method.A()
, method.B()
.
Usage
rds22
Format
Reference dataset 22
Simulated with CVwT = CVwR = 45%, CVbT = CVbR = 100% GMR 0.90. 42 subjects.
Balanced (21 subjects in each of the sequences) and complete (no missing data). No outliers.
A data frame with 126 observations on the following 5 variables:- rds22
-
subject
a factor with 42 levels: 1, 2, ..., 42 period
a factor with 3 levels: 1, 2, 3 sequence
a factor with 2 levels: TRR, RTR treatment
a factor with 2 levels: T, R PK
a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally Cmax) logPK
a numeric vector of the natural logarithms of PK
Details
Dataset | N | CwR (%) | Evaluation |
rds22 | 42 | >30 | method.A() , method.B()
|
Note
In software sequences and treatments are ranked in lexical order. Hence, executing str()
or summary()
will show sequence
as "RTR", "TRR"
and treatment
as "R", "T"
. In BE – by convention – sequences are ordered with T
first. The package follows this convention.
This partial replicate design is also known as the ‘extra-reference design’. Since the Test is not administered in all periods, lacking period effects must be assumed. In the presence of true period effects the treatment comparison will be biased. Hence, this design is not recommended.
Author(s)
Helmut Schütz (R-code for simulations by Detlew Labes)
Source
Dataset | Origin | Description |
rds22 | R | Simulated with homoscedasticity. |
Examples
str(rds22)
rds22[61:66, ]
summary(rds22[2:5])