TRTR.RTRT.TRRT.RTTR {replicateBE} | R Documentation |
Reference Dataset for TRTR|RTRT|TRRT|RTTR Designs
Description
Dataset from the public domain to be evaluated by method.A()
and/or method.B()
.
Format
Reference Dataset 23
22 subjects.
Unbalanced (four subjects in sequence RTRT and six in each of the other three) and complete. Two outliers (subjects 8 and 17) in sequence TRTR.
A data frame with 88 observations on the following 5 variables:- rds23
-
subject
a factor with 22 levels: 1, 2, ..., 27 period
a factor with 4 levels: 1, 2, 3, 4 sequence
a factor with 4 levels: TRTR, RTRT, TRRT, RTTR treatment
a factor with 2 levels: T, R PK
a numeric vector of pharmacokinetic responses acceptable for reference-scaling (here Cmax)
Details
Dataset | N | CVwR (%) | Evaluation |
rds23 | 22 | >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 "RTRT", "RTTR", "TRRT", "TRTR"
and treatment
as "R", "T"
. In BE – by convention – sequences are ordered with T
first. The package follows this convention.
Source
Data set | Origin | Description |
rds23 | FDA, CDER | Cmax data of Drug 7. |
References
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Bioequivalence Studies. Rockville, 1997. bioequivalence study files (archived 2017-07-23)
Examples
str(rds23)
row <- c(25:28, 5:8, 9:12, 1:4)
rds23[row, ]
summary(rds23[2:5])