TRTR.RTRT.TRRT.RTTR: Reference Dataset for TRTR|RTRT|TRRT|RTTR Designs

In replicateBE: Average Bioequivalence with Expanding Limits (ABEL)

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])

replicateBE documentation built on May 3, 2022, 1:06 a.m.